EUTHYROX-美国FDA药品数据库-药物在线

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

>>>原始批准或临时批准<<<

审批日期	提交号	审批结论	提交分类	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
2002/05/31	ORIG-1（原始申请）	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD ;Orphan	Review Letter Label

>>>补充申请<<<

审批日期	提交号	审批结论	补充类别或审批类型	审评优先级；罕用药状态	通知信、审评文件、说明书、包装标签
2022/04/27	SUPPL-10（补充）	Approval	Labeling-Container/Carton Labels,Labeling-Package Insert	STANDARD	Letter Label
2018/09/14	SUPPL-6（补充）	Approval	Labeling-Package Insert	STANDARD	Label Letter
2018/09/14	SUPPL-5（补充）	Approval	Labeling-Package Insert	STANDARD	Label Letter
2018/09/14	SUPPL-4（补充）	Approval	Efficacy-Accelerated Approval Confirmatory Study	STANDARD	Label Letter
2009/03/26	SUPPL-2（补充）	Approval	Labeling	STANDARD	Label Letter

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	RLD	RS	TE 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	EMD SERONO 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	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	RLD	RS	TE 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	EMD SERONO 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	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	RLD	RS	TE 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	EMD SERONO 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	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	RLD	RS	TE 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	EMD SERONO 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	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	RLD	RS	TE 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	EMD SERONO 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	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	RLD	RS	TE 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	EMD SERONO 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	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	RLD	RS	TE 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	EMD SERONO 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	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	RLD	RS	TE 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	EMD SERONO INC
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	RLD	RS	TE 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	EMD SERONO 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	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	RLD	RS	TE 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	EMD SERONO 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	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	RLD	RS	TE 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	EMD SERONO 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	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