药品注册申请号：021301
申请类型：NDA (新药申请)
申请人：KING PHARMS
申请人全名：KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT LLC
产品信息
产品号商品名活性成分剂型/给药途径规格/剂量参比药物(RLD)生物等效参考标准(RS)治疗等效代码该申请号批准日期该产品号批准日期市场状态
001 LEVOXYL LEVOTHYROXINE SODIUM TABLET;ORAL 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Yes No AB1;AB3 2001/05/25 2001/05/25 Prescription
002 LEVOXYL LEVOTHYROXINE SODIUM TABLET;ORAL 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Yes No AB1;AB3 2001/05/25 Prescription
003 LEVOXYL LEVOTHYROXINE SODIUM TABLET;ORAL 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Yes No AB1;AB3 2001/05/25 Prescription
004 LEVOXYL LEVOTHYROXINE SODIUM TABLET;ORAL 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Yes No AB1;AB3 2001/05/25 Prescription
005 LEVOXYL LEVOTHYROXINE SODIUM TABLET;ORAL 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Yes No AB1;AB3 2001/05/25 Prescription
006 LEVOXYL LEVOTHYROXINE SODIUM TABLET;ORAL 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Yes No AB1;AB3 2001/05/25 Prescription
007 LEVOXYL LEVOTHYROXINE SODIUM TABLET;ORAL 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Yes No AB1;AB3 2001/05/25 Prescription
008 LEVOXYL LEVOTHYROXINE SODIUM TABLET;ORAL 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Yes No AB1;AB3 2001/05/25 Prescription
009 LEVOXYL LEVOTHYROXINE SODIUM TABLET;ORAL 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Yes No AB1;AB3 2001/05/25 Prescription
010 LEVOXYL LEVOTHYROXINE SODIUM TABLET;ORAL 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Yes No AB1;AB3 2001/05/25 Prescription
011 LEVOXYL LEVOTHYROXINE SODIUM TABLET;ORAL 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Yes Yes AB1;AB3 2001/05/25 Prescription
012 LEVOXYL LEVOTHYROXINE SODIUM TABLET;ORAL 0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No None 2001/05/25 Discontinued
批准日期，申请提交历史，通知信，药品说明书，审评文件等信息
提交状态日期提交号审批结论申请内容分类审评优先级；罕用药状态通知信、审评文件、说明书、包装标签备注
2018/12/20 SUPPL-38（补充） Approval Labeling STANDARD
2014/11/05 SUPPL-37（补充） Approval Manufacturing (CMC) STANDARD
2014/05/06 SUPPL-35（补充） Approval Manufacturing (CMC) STANDARD
2012/12/14 SUPPL-34（补充） Approval Manufacturing (CMC) STANDARD
2011/03/21 SUPPL-27（补充） Approval Manufacturing (CMC) N/A
2009/09/01 SUPPL-28（补充） Approval Supplement STANDARD
2008/07/08 SUPPL-26（补充） Approval Labeling STANDARD
2005/03/08 SUPPL-14（补充） Approval Labeling STANDARD
2003/07/23 SUPPL-6（补充） Approval Manufacturing (CMC) STANDARD
2002/12/31 SUPPL-3（补充） Approval Manufacturing (CMC) STANDARD
2002/07/17 SUPPL-2（补充） Approval Labeling STANDARD
2002/04/03 SUPPL-1（补充） Approval Manufacturing (CMC) STANDARD
2001/05/25 ORIG-1（原始申请） Approval Type 5 - New Formulation or New Manufacturer STANDARD
与本品相关的专利信息（来自FDA橙皮书Orange Book）
关联产品号专利号专利过期日是否物质专利是否产品专利专利用途代码撤销请求提交日期专利下载备注
001 6555581 2022/02/15 PDF格式**本条是由Drugfuture回溯的历史信息**
7067148 2022/02/15 Y PDF格式**本条是由Drugfuture回溯的历史信息**
7101569 2022/08/14 U-759 PDF格式**本条是由Drugfuture回溯的历史信息**
7101569 2023/10/02 U-759 PDF格式**本条是由Drugfuture回溯的历史信息**
002 6555581 2022/02/15 PDF格式**本条是由Drugfuture回溯的历史信息**
7067148 2022/02/15 Y PDF格式**本条是由Drugfuture回溯的历史信息**
7101569 2022/08/14 U-759 PDF格式**本条是由Drugfuture回溯的历史信息**
7101569 2023/10/02 U-759 PDF格式**本条是由Drugfuture回溯的历史信息**
003 6555581 2022/02/15 PDF格式**本条是由Drugfuture回溯的历史信息**
7067148 2022/02/15 Y PDF格式**本条是由Drugfuture回溯的历史信息**
7101569 2022/08/14 U-759 PDF格式**本条是由Drugfuture回溯的历史信息**
7101569 2023/10/02 U-759 PDF格式**本条是由Drugfuture回溯的历史信息**
004 6555581 2022/02/15 PDF格式**本条是由Drugfuture回溯的历史信息**
7067148 2022/02/15 Y PDF格式**本条是由Drugfuture回溯的历史信息**
7101569 2022/08/14 U-759 PDF格式**本条是由Drugfuture回溯的历史信息**
7101569 2023/10/02 U-759 PDF格式**本条是由Drugfuture回溯的历史信息**
005 6555581 2022/02/15 PDF格式**本条是由Drugfuture回溯的历史信息**
7067148 2022/02/15 Y PDF格式**本条是由Drugfuture回溯的历史信息**
7101569 2022/08/14 U-759 PDF格式**本条是由Drugfuture回溯的历史信息**
7101569 2023/10/02 U-759 PDF格式**本条是由Drugfuture回溯的历史信息**
006 6555581 2022/02/15 PDF格式**本条是由Drugfuture回溯的历史信息**
7067148 2022/02/15 Y PDF格式**本条是由Drugfuture回溯的历史信息**
7101569 2022/08/14 U-759 PDF格式**本条是由Drugfuture回溯的历史信息**
7101569 2023/10/02 U-759 PDF格式**本条是由Drugfuture回溯的历史信息**
007 6555581 2022/02/15 PDF格式**本条是由Drugfuture回溯的历史信息**
7067148 2022/02/15 Y PDF格式**本条是由Drugfuture回溯的历史信息**
7101569 2022/08/14 U-759 PDF格式**本条是由Drugfuture回溯的历史信息**
7101569 2023/10/02 U-759 PDF格式**本条是由Drugfuture回溯的历史信息**
008 6555581 2022/02/15 PDF格式**本条是由Drugfuture回溯的历史信息**
7067148 2022/02/15 Y PDF格式**本条是由Drugfuture回溯的历史信息**
7101569 2022/08/14 U-759 PDF格式**本条是由Drugfuture回溯的历史信息**
7101569 2023/10/02 U-759 PDF格式**本条是由Drugfuture回溯的历史信息**
009 6555581 2022/02/15 PDF格式**本条是由Drugfuture回溯的历史信息**
7067148 2022/02/15 Y PDF格式**本条是由Drugfuture回溯的历史信息**
7101569 2022/08/14 U-759 PDF格式**本条是由Drugfuture回溯的历史信息**
7101569 2023/10/02 U-759 PDF格式**本条是由Drugfuture回溯的历史信息**
010 6555581 2022/02/15 PDF格式**本条是由Drugfuture回溯的历史信息**
7067148 2022/02/15 Y PDF格式**本条是由Drugfuture回溯的历史信息**
7101569 2022/08/14 U-759 PDF格式**本条是由Drugfuture回溯的历史信息**
7101569 2023/10/02 U-759 PDF格式**本条是由Drugfuture回溯的历史信息**
011 6555581 2022/02/15 PDF格式**本条是由Drugfuture回溯的历史信息**
7067148 2022/02/15 Y PDF格式**本条是由Drugfuture回溯的历史信息**
7101569 2022/08/14 U-759 PDF格式**本条是由Drugfuture回溯的历史信息**
7101569 2023/10/02 U-759 PDF格式**本条是由Drugfuture回溯的历史信息**
012 6555581 2022/02/15 PDF格式**本条是由Drugfuture回溯的历史信息**
7067148 2022/02/15 Y PDF格式**本条是由Drugfuture回溯的历史信息**
7101569 2022/08/14 U-759 PDF格式**本条是由Drugfuture回溯的历史信息**
7101569 2023/10/02 U-759 PDF格式**本条是由Drugfuture回溯的历史信息**
与本品相关的市场独占权保护信息
关联产品号独占权代码失效日期备注
无
与本品治疗等效的药品
活性成分:LEVOTHYROXINE SODIUM 剂型/给药途径:TABLET;ORAL 规格:0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium 治疗等效代码:AB1
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021210 001 NDA UNITHROID LEVOTHYROXINE SODIUM TABLET;ORAL 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2000/08/21 STEVENS J
021301 001 NDA LEVOXYL LEVOTHYROXINE SODIUM TABLET;ORAL 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2001/05/25 KING PHARMS
021342 001 NDA LEVO-T LEVOTHYROXINE SODIUM TABLET;ORAL 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2002/03/01 CEDIPROF INC
076187 001 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2002/06/05 MYLAN
021402 001 NDA SYNTHROID LEVOTHYROXINE SODIUM TABLET;ORAL 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2002/07/24 ABBVIE
021116 001 NDA THYRO-TABS LEVOTHYROXINE SODIUM TABLET;ORAL 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2002/10/24 ALVOGEN
021137 001 NDA LEVOLET LEVOTHYROXINE SODIUM TABLET;ORAL 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2003/06/06 GENUS LIFESCIENCES
209713 001 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2019/01/18 LUPIN
212399 001 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2020/10/19 ACCORD HLTHCARE
207588 001 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2022/05/10 WATSON LABS TEVA
活性成分:LEVOTHYROXINE SODIUM 剂型/给药途径:TABLET;ORAL 规格:0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium 治疗等效代码:AB3
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021210 001 NDA UNITHROID LEVOTHYROXINE SODIUM TABLET;ORAL 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB3 2000/08/21 STEVENS J
021301 001 NDA LEVOXYL LEVOTHYROXINE SODIUM TABLET;ORAL 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB3 2001/05/25 KING PHARMS
021342 001 NDA LEVO-T LEVOTHYROXINE SODIUM TABLET;ORAL 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2002/03/01 CEDIPROF INC
076187 001 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2002/06/05 MYLAN
021116 001 NDA THYRO-TABS LEVOTHYROXINE SODIUM TABLET;ORAL 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB3 2002/10/24 ALVOGEN
021137 001 NDA LEVOLET LEVOTHYROXINE SODIUM TABLET;ORAL 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2003/06/06 GENUS LIFESCIENCES
209713 001 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2019/01/18 LUPIN
212399 001 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2020/10/19 ACCORD HLTHCARE
207588 001 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2022/05/10 WATSON LABS TEVA
活性成分:LEVOTHYROXINE SODIUM 剂型/给药途径:TABLET;ORAL 规格:0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium 治疗等效代码:AB1
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021210 002 NDA UNITHROID LEVOTHYROXINE SODIUM TABLET;ORAL 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2000/08/21 STEVENS J
021301 002 NDA LEVOXYL LEVOTHYROXINE SODIUM TABLET;ORAL 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2001/05/25 KING PHARMS
021342 002 NDA LEVO-T LEVOTHYROXINE SODIUM TABLET;ORAL 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2002/03/01 CEDIPROF INC
076187 002 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2002/06/05 MYLAN
021402 002 NDA SYNTHROID LEVOTHYROXINE SODIUM TABLET;ORAL 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2002/07/24 ABBVIE
021116 002 NDA THYRO-TABS LEVOTHYROXINE SODIUM TABLET;ORAL 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2002/10/24 ALVOGEN
021137 002 NDA LEVOLET LEVOTHYROXINE SODIUM TABLET;ORAL 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2003/06/06 GENUS LIFESCIENCES
209713 002 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2019/01/18 LUPIN
212399 002 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2020/10/19 ACCORD HLTHCARE
207588 002 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2022/05/10 WATSON LABS TEVA
活性成分:LEVOTHYROXINE SODIUM 剂型/给药途径:TABLET;ORAL 规格:0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium 治疗等效代码:AB3
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021210 002 NDA UNITHROID LEVOTHYROXINE SODIUM TABLET;ORAL 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB3 2000/08/21 STEVENS J
021301 002 NDA LEVOXYL LEVOTHYROXINE SODIUM TABLET;ORAL 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB3 2001/05/25 KING PHARMS
021342 002 NDA LEVO-T LEVOTHYROXINE SODIUM TABLET;ORAL 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2002/03/01 CEDIPROF INC
076187 002 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2002/06/05 MYLAN
021116 002 NDA THYRO-TABS LEVOTHYROXINE SODIUM TABLET;ORAL 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB3 2002/10/24 ALVOGEN
021137 002 NDA LEVOLET LEVOTHYROXINE SODIUM TABLET;ORAL 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2003/06/06 GENUS LIFESCIENCES
209713 002 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2019/01/18 LUPIN
212399 002 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2020/10/19 ACCORD HLTHCARE
207588 002 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2022/05/10 WATSON LABS TEVA
活性成分:LEVOTHYROXINE SODIUM 剂型/给药途径:TABLET;ORAL 规格:0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium 治疗等效代码:AB1
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021210 003 NDA UNITHROID LEVOTHYROXINE SODIUM TABLET;ORAL 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2000/08/21 STEVENS J
021301 003 NDA LEVOXYL LEVOTHYROXINE SODIUM TABLET;ORAL 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2001/05/25 KING PHARMS
021342 003 NDA LEVO-T LEVOTHYROXINE SODIUM TABLET;ORAL 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2002/03/01 CEDIPROF INC
076187 003 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2002/06/05 MYLAN
021402 003 NDA SYNTHROID LEVOTHYROXINE SODIUM TABLET;ORAL 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2002/07/24 ABBVIE
021116 003 NDA THYRO-TABS LEVOTHYROXINE SODIUM TABLET;ORAL 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2002/10/24 ALVOGEN
021137 003 NDA LEVOLET LEVOTHYROXINE SODIUM TABLET;ORAL 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2003/06/06 GENUS LIFESCIENCES
209713 003 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2019/01/18 LUPIN
212399 003 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2020/10/19 ACCORD HLTHCARE
207588 003 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2022/05/10 WATSON LABS TEVA
活性成分:LEVOTHYROXINE SODIUM 剂型/给药途径:TABLET;ORAL 规格:0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium 治疗等效代码:AB3
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021210 003 NDA UNITHROID LEVOTHYROXINE SODIUM TABLET;ORAL 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB3 2000/08/21 STEVENS J
021301 003 NDA LEVOXYL LEVOTHYROXINE SODIUM TABLET;ORAL 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB3 2001/05/25 KING PHARMS
021342 003 NDA LEVO-T LEVOTHYROXINE SODIUM TABLET;ORAL 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2002/03/01 CEDIPROF INC
076187 003 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2002/06/05 MYLAN
021116 003 NDA THYRO-TABS LEVOTHYROXINE SODIUM TABLET;ORAL 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB3 2002/10/24 ALVOGEN
021137 003 NDA LEVOLET LEVOTHYROXINE SODIUM TABLET;ORAL 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2003/06/06 GENUS LIFESCIENCES
209713 003 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2019/01/18 LUPIN
212399 003 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2020/10/19 ACCORD HLTHCARE
207588 003 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2022/05/10 WATSON LABS TEVA
活性成分:LEVOTHYROXINE SODIUM 剂型/给药途径:TABLET;ORAL 规格:0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium 治疗等效代码:AB1
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021210 004 NDA UNITHROID LEVOTHYROXINE SODIUM TABLET;ORAL 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2000/08/21 STEVENS J
021301 004 NDA LEVOXYL LEVOTHYROXINE SODIUM TABLET;ORAL 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2001/05/25 KING PHARMS
021342 004 NDA LEVO-T LEVOTHYROXINE SODIUM TABLET;ORAL 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2002/03/01 CEDIPROF INC
076187 004 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2002/06/05 MYLAN
021402 004 NDA SYNTHROID LEVOTHYROXINE SODIUM TABLET;ORAL 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2002/07/24 ABBVIE
021116 010 NDA THYRO-TABS LEVOTHYROXINE SODIUM TABLET;ORAL 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2002/10/24 ALVOGEN
021137 004 NDA LEVOLET LEVOTHYROXINE SODIUM TABLET;ORAL 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2003/06/06 GENUS LIFESCIENCES
209713 004 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2019/01/18 LUPIN
212399 004 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2020/10/19 ACCORD HLTHCARE
207588 004 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2022/05/10 WATSON LABS TEVA
活性成分:LEVOTHYROXINE SODIUM 剂型/给药途径:TABLET;ORAL 规格:0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium 治疗等效代码:AB3
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021210 004 NDA UNITHROID LEVOTHYROXINE SODIUM TABLET;ORAL 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB3 2000/08/21 STEVENS J
021301 004 NDA LEVOXYL LEVOTHYROXINE SODIUM TABLET;ORAL 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB3 2001/05/25 KING PHARMS
021342 004 NDA LEVO-T LEVOTHYROXINE SODIUM TABLET;ORAL 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2002/03/01 CEDIPROF INC
076187 004 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2002/06/05 MYLAN
021116 010 NDA THYRO-TABS LEVOTHYROXINE SODIUM TABLET;ORAL 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB3 2002/10/24 ALVOGEN
021137 004 NDA LEVOLET LEVOTHYROXINE SODIUM TABLET;ORAL 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2003/06/06 GENUS LIFESCIENCES
209713 004 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2019/01/18 LUPIN
212399 004 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2020/10/19 ACCORD HLTHCARE
207588 004 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2022/05/10 WATSON LABS TEVA
活性成分:LEVOTHYROXINE SODIUM 剂型/给药途径:TABLET;ORAL 规格:0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium 治疗等效代码:AB1
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021210 005 NDA UNITHROID LEVOTHYROXINE SODIUM TABLET;ORAL 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2000/08/21 STEVENS J
021301 005 NDA LEVOXYL LEVOTHYROXINE SODIUM TABLET;ORAL 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2001/05/25 KING PHARMS
021342 005 NDA LEVO-T LEVOTHYROXINE SODIUM TABLET;ORAL 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2002/03/01 CEDIPROF INC
076187 005 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2002/06/05 MYLAN
021402 005 NDA SYNTHROID LEVOTHYROXINE SODIUM TABLET;ORAL 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2002/07/24 ABBVIE
021116 004 NDA THYRO-TABS LEVOTHYROXINE SODIUM TABLET;ORAL 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2002/10/24 ALVOGEN
021137 005 NDA LEVOLET LEVOTHYROXINE SODIUM TABLET;ORAL 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2003/06/06 GENUS LIFESCIENCES
209713 005 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2019/01/18 LUPIN
212399 005 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2020/10/19 ACCORD HLTHCARE
207588 005 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2022/05/10 WATSON LABS TEVA
活性成分:LEVOTHYROXINE SODIUM 剂型/给药途径:TABLET;ORAL 规格:0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium 治疗等效代码:AB3
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021210 005 NDA UNITHROID LEVOTHYROXINE SODIUM TABLET;ORAL 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB3 2000/08/21 STEVENS J
021301 005 NDA LEVOXYL LEVOTHYROXINE SODIUM TABLET;ORAL 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB3 2001/05/25 KING PHARMS
021342 005 NDA LEVO-T LEVOTHYROXINE SODIUM TABLET;ORAL 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2002/03/01 CEDIPROF INC
076187 005 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2002/06/05 MYLAN
021116 004 NDA THYRO-TABS LEVOTHYROXINE SODIUM TABLET;ORAL 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB3 2002/10/24 ALVOGEN
021137 005 NDA LEVOLET LEVOTHYROXINE SODIUM TABLET;ORAL 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2003/06/06 GENUS LIFESCIENCES
209713 005 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2019/01/18 LUPIN
212399 005 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2020/10/19 ACCORD HLTHCARE
207588 005 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2022/05/10 WATSON LABS TEVA
活性成分:LEVOTHYROXINE SODIUM 剂型/给药途径:TABLET;ORAL 规格:0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium 治疗等效代码:AB1
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021210 006 NDA UNITHROID LEVOTHYROXINE SODIUM TABLET;ORAL 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2000/08/21 STEVENS J
021301 006 NDA LEVOXYL LEVOTHYROXINE SODIUM TABLET;ORAL 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2001/05/25 KING PHARMS
021342 006 NDA LEVO-T LEVOTHYROXINE SODIUM TABLET;ORAL 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2002/03/01 CEDIPROF INC
076187 006 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2002/06/05 MYLAN
021402 006 NDA SYNTHROID LEVOTHYROXINE SODIUM TABLET;ORAL 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2002/07/24 ABBVIE
021116 011 NDA THYRO-TABS LEVOTHYROXINE SODIUM TABLET;ORAL 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2002/10/24 ALVOGEN
021137 006 NDA LEVOLET LEVOTHYROXINE SODIUM TABLET;ORAL 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2003/06/06 GENUS LIFESCIENCES
209713 006 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2019/01/18 LUPIN
212399 006 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2020/10/19 ACCORD HLTHCARE
207588 006 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2022/05/10 WATSON LABS TEVA
活性成分:LEVOTHYROXINE SODIUM 剂型/给药途径:TABLET;ORAL 规格:0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium 治疗等效代码:AB3
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021210 006 NDA UNITHROID LEVOTHYROXINE SODIUM TABLET;ORAL 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB3 2000/08/21 STEVENS J
021301 006 NDA LEVOXYL LEVOTHYROXINE SODIUM TABLET;ORAL 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB3 2001/05/25 KING PHARMS
021342 006 NDA LEVO-T LEVOTHYROXINE SODIUM TABLET;ORAL 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2002/03/01 CEDIPROF INC
076187 006 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2002/06/05 MYLAN
021116 011 NDA THYRO-TABS LEVOTHYROXINE SODIUM TABLET;ORAL 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB3 2002/10/24 ALVOGEN
021137 006 NDA LEVOLET LEVOTHYROXINE SODIUM TABLET;ORAL 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2003/06/06 GENUS LIFESCIENCES
209713 006 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2019/01/18 LUPIN
212399 006 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2020/10/19 ACCORD HLTHCARE
207588 006 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2022/05/10 WATSON LABS TEVA
活性成分:LEVOTHYROXINE SODIUM 剂型/给药途径:TABLET;ORAL 规格:0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium 治疗等效代码:AB1
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021210 007 NDA UNITHROID LEVOTHYROXINE SODIUM TABLET;ORAL 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2000/08/21 STEVENS J
021301 007 NDA LEVOXYL LEVOTHYROXINE SODIUM TABLET;ORAL 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2001/05/25 KING PHARMS
021342 007 NDA LEVO-T LEVOTHYROXINE SODIUM TABLET;ORAL 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2002/03/01 CEDIPROF INC
076187 007 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2002/06/05 MYLAN
021402 007 NDA SYNTHROID LEVOTHYROXINE SODIUM TABLET;ORAL 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2002/07/24 ABBVIE
021116 005 NDA THYRO-TABS LEVOTHYROXINE SODIUM TABLET;ORAL 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2002/10/24 ALVOGEN
021137 007 NDA LEVOLET LEVOTHYROXINE SODIUM TABLET;ORAL 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2003/06/06 GENUS LIFESCIENCES
209713 007 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2019/01/18 LUPIN
212399 007 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2020/10/19 ACCORD HLTHCARE
207588 007 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2022/05/10 WATSON LABS TEVA
活性成分:LEVOTHYROXINE SODIUM 剂型/给药途径:TABLET;ORAL 规格:0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium 治疗等效代码:AB3
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021210 007 NDA UNITHROID LEVOTHYROXINE SODIUM TABLET;ORAL 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB3 2000/08/21 STEVENS J
021301 007 NDA LEVOXYL LEVOTHYROXINE SODIUM TABLET;ORAL 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB3 2001/05/25 KING PHARMS
021342 007 NDA LEVO-T LEVOTHYROXINE SODIUM TABLET;ORAL 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2002/03/01 CEDIPROF INC
076187 007 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2002/06/05 MYLAN
021116 005 NDA THYRO-TABS LEVOTHYROXINE SODIUM TABLET;ORAL 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB3 2002/10/24 ALVOGEN
021137 007 NDA LEVOLET LEVOTHYROXINE SODIUM TABLET;ORAL 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2003/06/06 GENUS LIFESCIENCES
209713 007 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2019/01/18 LUPIN
212399 007 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2020/10/19 ACCORD HLTHCARE
207588 007 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2022/05/10 WATSON LABS TEVA
活性成分:LEVOTHYROXINE SODIUM 剂型/给药途径:TABLET;ORAL 规格:0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium 治疗等效代码:AB1
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021301 008 NDA LEVOXYL LEVOTHYROXINE SODIUM TABLET;ORAL 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2001/05/25 KING PHARMS
021402 008 NDA SYNTHROID LEVOTHYROXINE SODIUM TABLET;ORAL 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2002/07/24 ABBVIE
021137 008 NDA LEVOLET LEVOTHYROXINE SODIUM TABLET;ORAL 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2003/06/06 GENUS LIFESCIENCES
021342 012 NDA LEVO-T LEVOTHYROXINE SODIUM TABLET;ORAL 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2003/12/08 CEDIPROF INC
021116 012 NDA THYRO-TABS LEVOTHYROXINE SODIUM TABLET;ORAL 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2004/12/07 ALVOGEN
076187 012 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2006/12/13 MYLAN
021210 012 NDA UNITHROID LEVOTHYROXINE SODIUM TABLET;ORAL 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2008/02/08 STEVENS J
209713 008 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2019/01/18 LUPIN
212399 008 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2020/10/19 ACCORD HLTHCARE
207588 008 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2022/05/10 WATSON LABS TEVA
活性成分:LEVOTHYROXINE SODIUM 剂型/给药途径:TABLET;ORAL 规格:0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium 治疗等效代码:AB3
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021301 008 NDA LEVOXYL LEVOTHYROXINE SODIUM TABLET;ORAL 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB3 2001/05/25 KING PHARMS
021137 008 NDA LEVOLET LEVOTHYROXINE SODIUM TABLET;ORAL 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2003/06/06 GENUS LIFESCIENCES
021342 012 NDA LEVO-T LEVOTHYROXINE SODIUM TABLET;ORAL 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2003/12/08 CEDIPROF INC
021116 012 NDA THYRO-TABS LEVOTHYROXINE SODIUM TABLET;ORAL 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB3 2004/12/07 ALVOGEN
076187 012 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2006/12/13 MYLAN
021210 012 NDA UNITHROID LEVOTHYROXINE SODIUM TABLET;ORAL 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB3 2008/02/08 STEVENS J
209713 008 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2019/01/18 LUPIN
212399 008 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2020/10/19 ACCORD HLTHCARE
207588 008 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2022/05/10 WATSON LABS TEVA
活性成分:LEVOTHYROXINE SODIUM 剂型/给药途径:TABLET;ORAL 规格:0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium 治疗等效代码:AB1
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021210 008 NDA UNITHROID LEVOTHYROXINE SODIUM TABLET;ORAL 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2000/08/21 STEVENS J
021301 009 NDA LEVOXYL LEVOTHYROXINE SODIUM TABLET;ORAL 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2001/05/25 KING PHARMS
021342 008 NDA LEVO-T LEVOTHYROXINE SODIUM TABLET;ORAL 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2002/03/01 CEDIPROF INC
076187 008 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2002/06/05 MYLAN
021402 009 NDA SYNTHROID LEVOTHYROXINE SODIUM TABLET;ORAL 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2002/07/24 ABBVIE
021116 006 NDA THYRO-TABS LEVOTHYROXINE SODIUM TABLET;ORAL 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2002/10/24 ALVOGEN
021137 009 NDA LEVOLET LEVOTHYROXINE SODIUM TABLET;ORAL 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2003/06/06 GENUS LIFESCIENCES
209713 009 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2019/01/18 LUPIN
212399 009 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2020/10/19 ACCORD HLTHCARE
207588 009 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2022/05/10 WATSON LABS TEVA
活性成分:LEVOTHYROXINE SODIUM 剂型/给药途径:TABLET;ORAL 规格:0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium 治疗等效代码:AB3
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021210 008 NDA UNITHROID LEVOTHYROXINE SODIUM TABLET;ORAL 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB3 2000/08/21 STEVENS J
021301 009 NDA LEVOXYL LEVOTHYROXINE SODIUM TABLET;ORAL 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB3 2001/05/25 KING PHARMS
021342 008 NDA LEVO-T LEVOTHYROXINE SODIUM TABLET;ORAL 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2002/03/01 CEDIPROF INC
076187 008 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2002/06/05 MYLAN
021116 006 NDA THYRO-TABS LEVOTHYROXINE SODIUM TABLET;ORAL 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB3 2002/10/24 ALVOGEN
021137 009 NDA LEVOLET LEVOTHYROXINE SODIUM TABLET;ORAL 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2003/06/06 GENUS LIFESCIENCES
209713 009 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2019/01/18 LUPIN
212399 009 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2020/10/19 ACCORD HLTHCARE
207588 009 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2022/05/10 WATSON LABS TEVA
活性成分:LEVOTHYROXINE SODIUM 剂型/给药途径:TABLET;ORAL 规格:0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium 治疗等效代码:AB1
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021210 009 NDA UNITHROID LEVOTHYROXINE SODIUM TABLET;ORAL 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2000/08/21 STEVENS J
021301 010 NDA LEVOXYL LEVOTHYROXINE SODIUM TABLET;ORAL 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2001/05/25 KING PHARMS
021342 009 NDA LEVO-T LEVOTHYROXINE SODIUM TABLET;ORAL 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2002/03/01 CEDIPROF INC
076187 009 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2002/06/05 MYLAN
021402 010 NDA SYNTHROID LEVOTHYROXINE SODIUM TABLET;ORAL 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2002/07/24 ABBVIE
021116 007 NDA THYRO-TABS LEVOTHYROXINE SODIUM TABLET;ORAL 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2002/10/24 ALVOGEN
021137 010 NDA LEVOLET LEVOTHYROXINE SODIUM TABLET;ORAL 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2003/06/06 GENUS LIFESCIENCES
209713 010 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2019/01/18 LUPIN
212399 010 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2020/10/19 ACCORD HLTHCARE
207588 010 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2022/05/10 WATSON LABS TEVA
活性成分:LEVOTHYROXINE SODIUM 剂型/给药途径:TABLET;ORAL 规格:0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium 治疗等效代码:AB3
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021210 009 NDA UNITHROID LEVOTHYROXINE SODIUM TABLET;ORAL 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB3 2000/08/21 STEVENS J
021301 010 NDA LEVOXYL LEVOTHYROXINE SODIUM TABLET;ORAL 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB3 2001/05/25 KING PHARMS
021342 009 NDA LEVO-T LEVOTHYROXINE SODIUM TABLET;ORAL 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2002/03/01 CEDIPROF INC
076187 009 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2002/06/05 MYLAN
021116 007 NDA THYRO-TABS LEVOTHYROXINE SODIUM TABLET;ORAL 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB3 2002/10/24 ALVOGEN
021137 010 NDA LEVOLET LEVOTHYROXINE SODIUM TABLET;ORAL 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2003/06/06 GENUS LIFESCIENCES
209713 010 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2019/01/18 LUPIN
212399 010 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2020/10/19 ACCORD HLTHCARE
207588 010 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2022/05/10 WATSON LABS TEVA
活性成分:LEVOTHYROXINE SODIUM 剂型/给药途径:TABLET;ORAL 规格:0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium 治疗等效代码:AB1
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021210 010 NDA UNITHROID LEVOTHYROXINE SODIUM TABLET;ORAL 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2000/08/21 STEVENS J
021301 011 NDA LEVOXYL LEVOTHYROXINE SODIUM TABLET;ORAL 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes Yes AB1 2001/05/25 KING PHARMS
021342 010 NDA LEVO-T LEVOTHYROXINE SODIUM TABLET;ORAL 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2002/03/01 CEDIPROF INC
076187 010 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2002/06/05 MYLAN
021402 012 NDA SYNTHROID LEVOTHYROXINE SODIUM TABLET;ORAL 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2002/07/24 ABBVIE
021116 008 NDA THYRO-TABS LEVOTHYROXINE SODIUM TABLET;ORAL 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB1 2002/10/24 ALVOGEN
021137 011 NDA LEVOLET LEVOTHYROXINE SODIUM TABLET;ORAL 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2003/06/06 GENUS LIFESCIENCES
209713 011 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2019/01/18 LUPIN
212399 011 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2020/10/19 ACCORD HLTHCARE
207588 011 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB1 2022/05/10 WATSON LABS TEVA
活性成分:LEVOTHYROXINE SODIUM 剂型/给药途径:TABLET;ORAL 规格:0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium 治疗等效代码:AB3
申请号产品号申请类型商品名活性成分剂型/给药途径规格市场状态RLDRSTE Code产品号批准日期申请人
021210 010 NDA UNITHROID LEVOTHYROXINE SODIUM TABLET;ORAL 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB3 2000/08/21 STEVENS J
021301 011 NDA LEVOXYL LEVOTHYROXINE SODIUM TABLET;ORAL 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes Yes AB3 2001/05/25 KING PHARMS
021342 010 NDA LEVO-T LEVOTHYROXINE SODIUM TABLET;ORAL 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2002/03/01 CEDIPROF INC
076187 010 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2002/06/05 MYLAN
021116 008 NDA THYRO-TABS LEVOTHYROXINE SODIUM TABLET;ORAL 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB3 2002/10/24 ALVOGEN
021137 011 NDA LEVOLET LEVOTHYROXINE SODIUM TABLET;ORAL 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2003/06/06 GENUS LIFESCIENCES
209713 011 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2019/01/18 LUPIN
212399 011 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2020/10/19 ACCORD HLTHCARE
207588 011 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB3 2022/05/10 WATSON LABS TEVA
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