药品注册申请号：021292
申请类型：NDA (新药申请)
申请人：PROVELL
申请人全名：PROVELL PHARMACEUTICALS 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 EUTHYROX LEVOTHYROXINE SODIUM TABLET;ORAL 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium No No AB2 2002/05/31 2002/05/31 Prescription
002 EUTHYROX LEVOTHYROXINE SODIUM TABLET;ORAL 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium No No AB2 2002/05/31 Prescription
003 EUTHYROX LEVOTHYROXINE SODIUM TABLET;ORAL 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium No No AB2 2002/05/31 Prescription
004 EUTHYROX LEVOTHYROXINE SODIUM TABLET;ORAL 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium No No AB2 2002/05/31 Prescription
005 EUTHYROX LEVOTHYROXINE SODIUM TABLET;ORAL 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium No No AB2 2002/05/31 Prescription
006 EUTHYROX LEVOTHYROXINE SODIUM TABLET;ORAL 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium No No AB2 2002/05/31 Prescription
007 EUTHYROX LEVOTHYROXINE SODIUM TABLET;ORAL 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium No No AB2 2002/05/31 Prescription
008 EUTHYROX LEVOTHYROXINE SODIUM TABLET;ORAL 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium No No AB2 2002/05/31 Prescription
009 EUTHYROX LEVOTHYROXINE SODIUM TABLET;ORAL 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium No No AB2 2002/05/31 Prescription
010 EUTHYROX LEVOTHYROXINE SODIUM TABLET;ORAL 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium No No AB2 2002/05/31 Prescription
011 EUTHYROX LEVOTHYROXINE SODIUM TABLET;ORAL 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium No No AB2 2002/05/31 Prescription
012 EUTHYROX LEVOTHYROXINE SODIUM TABLET;ORAL 0.3MG No No None 2002/05/31 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
2022/04/27 SUPPL-10（补充） Approval Labeling STANDARD
2018/09/14 SUPPL-6（补充） Approval Labeling STANDARD
2018/09/14 SUPPL-5（补充） Approval Labeling STANDARD
2018/09/14 SUPPL-4（补充） Approval Efficacy STANDARD
2009/03/26 SUPPL-2（补充） Approval Labeling STANDARD
2002/05/31 ORIG-1（原始申请） Approval Type 5 - New Formulation or New Manufacturer STANDARD ;Orphan
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
无
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:AB2
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 AB2 2000/08/21 STEVENS J
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 AB2 2002/03/01 CEDIPROF INC
021292 001 NDA EUTHYROX LEVOTHYROXINE SODIUM TABLET;ORAL 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB2 2002/05/31 PROVELL
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 AB2 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 AB2 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 AB2 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 AB2 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 AB2 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 AB2 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 AB2 2022/05/10 WATSON LABS TEVA
211417 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 AB2 2022/12/21 MACLEODS PHARMS LTD
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:AB2
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 AB2 2000/08/21 STEVENS J
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 AB2 2002/03/01 CEDIPROF INC
021292 002 NDA EUTHYROX LEVOTHYROXINE SODIUM TABLET;ORAL 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB2 2002/05/31 PROVELL
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 AB2 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 AB2 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 AB2 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 AB2 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 AB2 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 AB2 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 AB2 2022/05/10 WATSON LABS TEVA
211417 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 AB2 2022/12/21 MACLEODS PHARMS LTD
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:AB2
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 AB2 2000/08/21 STEVENS J
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 AB2 2002/03/01 CEDIPROF INC
021292 003 NDA EUTHYROX LEVOTHYROXINE SODIUM TABLET;ORAL 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB2 2002/05/31 PROVELL
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 AB2 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 AB2 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 AB2 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 AB2 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 AB2 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 AB2 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 AB2 2022/05/10 WATSON LABS TEVA
211417 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 AB2 2022/12/21 MACLEODS PHARMS LTD
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:AB2
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 AB2 2000/08/21 STEVENS J
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 AB2 2002/03/01 CEDIPROF INC
021292 004 NDA EUTHYROX LEVOTHYROXINE SODIUM TABLET;ORAL 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB2 2002/05/31 PROVELL
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 AB2 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 AB2 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 AB2 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 AB2 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 AB2 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 AB2 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 AB2 2022/05/10 WATSON LABS TEVA
211417 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 AB2 2022/12/21 MACLEODS PHARMS LTD
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:AB2
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 AB2 2000/08/21 STEVENS J
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 AB2 2002/03/01 CEDIPROF INC
021292 005 NDA EUTHYROX LEVOTHYROXINE SODIUM TABLET;ORAL 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB2 2002/05/31 PROVELL
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 AB2 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 AB2 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 AB2 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 AB2 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 AB2 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 AB2 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 AB2 2022/05/10 WATSON LABS TEVA
211417 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 AB2 2022/12/21 MACLEODS PHARMS LTD
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:AB2
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 AB2 2000/08/21 STEVENS J
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 AB2 2002/03/01 CEDIPROF INC
021292 006 NDA EUTHYROX LEVOTHYROXINE SODIUM TABLET;ORAL 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB2 2002/05/31 PROVELL
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 AB2 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 AB2 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 AB2 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 AB2 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 AB2 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 AB2 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 AB2 2022/05/10 WATSON LABS TEVA
211417 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 AB2 2022/12/21 MACLEODS PHARMS LTD
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:AB2
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 AB2 2000/08/21 STEVENS J
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 AB2 2002/03/01 CEDIPROF INC
021292 007 NDA EUTHYROX LEVOTHYROXINE SODIUM TABLET;ORAL 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB2 2002/05/31 PROVELL
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 AB2 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 AB2 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 AB2 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 AB2 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 AB2 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 AB2 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 AB2 2022/05/10 WATSON LABS TEVA
211417 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 AB2 2022/12/21 MACLEODS PHARMS LTD
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:AB2
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
021292 008 NDA EUTHYROX LEVOTHYROXINE SODIUM TABLET;ORAL 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB2 2002/05/31 PROVELL
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 AB2 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 AB2 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 AB2 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 AB2 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 AB2 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 AB2 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 AB2 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 AB2 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 AB2 2022/05/10 WATSON LABS TEVA
211417 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 AB2 2022/12/21 MACLEODS PHARMS LTD
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:AB2
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 AB2 2000/08/21 STEVENS J
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 AB2 2002/03/01 CEDIPROF INC
021292 009 NDA EUTHYROX LEVOTHYROXINE SODIUM TABLET;ORAL 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB2 2002/05/31 PROVELL
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 AB2 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 AB2 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 AB2 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 AB2 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 AB2 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 AB2 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 AB2 2022/05/10 WATSON LABS TEVA
211417 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 AB2 2022/12/21 MACLEODS PHARMS LTD
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:AB2
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 AB2 2000/08/21 STEVENS J
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 AB2 2002/03/01 CEDIPROF INC
021292 010 NDA EUTHYROX LEVOTHYROXINE SODIUM TABLET;ORAL 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB2 2002/05/31 PROVELL
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 AB2 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 AB2 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 AB2 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 AB2 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 AB2 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 AB2 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 AB2 2022/05/10 WATSON LABS TEVA
211417 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 AB2 2022/12/21 MACLEODS PHARMS LTD
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:AB2
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 AB2 2000/08/21 STEVENS J
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 AB2 2002/03/01 CEDIPROF INC
021292 011 NDA EUTHYROX LEVOTHYROXINE SODIUM TABLET;ORAL 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB2 2002/05/31 PROVELL
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 AB2 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 AB2 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 AB2 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 AB2 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 AB2 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 AB2 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 AB2 2022/05/10 WATSON LABS TEVA
211417 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 AB2 2022/12/21 MACLEODS PHARMS LTD
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