药品注册申请号：215259
申请类型：ANDA (仿制药申请)
申请人：ASCENT PHARMS INC
申请人全名：ASCENT PHARMACEUTICALS INC
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 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.025MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium No No AB4 2023/01/18 2023/01/18 Prescription
002 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.05MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium No No AB4 2023/01/18 Prescription
003 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.075MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium No No AB4 2023/01/18 Prescription
004 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.088MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium No No AB4 2023/01/18 Prescription
005 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.1MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium No No AB4 2023/01/18 Prescription
006 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.112MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium No No AB4 2023/01/18 Prescription
007 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.125MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium No No AB4 2023/01/18 Prescription
008 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium No No AB4 2023/01/18 Prescription
009 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium No No AB4 2023/01/18 Prescription
010 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium No No AB4 2023/01/18 Prescription
011 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium No No AB4 2023/01/18 Prescription
012 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium No No AB4 2023/01/18 Prescription
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
2023/01/18 ORIG-1（原始申请） Approval 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
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:AB4
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
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 AB4 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 AB4 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 AB4 2003/06/06 GENUS LIFESCIENCES
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 AB4 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 AB4 2022/05/10 WATSON LABS TEVA
215259 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 AB4 2023/01/18 ASCENT PHARMS INC
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:AB4
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
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 AB4 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 AB4 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 AB4 2003/06/06 GENUS LIFESCIENCES
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 AB4 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 AB4 2022/05/10 WATSON LABS TEVA
215259 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 AB4 2023/01/18 ASCENT PHARMS INC
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:AB4
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
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 AB4 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 AB4 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 AB4 2003/06/06 GENUS LIFESCIENCES
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 AB4 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 AB4 2022/05/10 WATSON LABS TEVA
215259 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 AB4 2023/01/18 ASCENT PHARMS INC
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:AB4
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
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 AB4 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 AB4 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 AB4 2003/06/06 GENUS LIFESCIENCES
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 AB4 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 AB4 2022/05/10 WATSON LABS TEVA
215259 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 AB4 2023/01/18 ASCENT PHARMS INC
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:AB4
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
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 AB4 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 AB4 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 AB4 2003/06/06 GENUS LIFESCIENCES
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 AB4 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 AB4 2022/05/10 WATSON LABS TEVA
215259 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 AB4 2023/01/18 ASCENT PHARMS INC
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:AB4
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
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 AB4 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 AB4 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 AB4 2003/06/06 GENUS LIFESCIENCES
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 AB4 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 AB4 2022/05/10 WATSON LABS TEVA
215259 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 AB4 2023/01/18 ASCENT PHARMS INC
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:AB4
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
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 AB4 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 AB4 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 AB4 2003/06/06 GENUS LIFESCIENCES
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 AB4 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 AB4 2022/05/10 WATSON LABS TEVA
215259 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 AB4 2023/01/18 ASCENT PHARMS INC
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:AB4
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
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 AB4 2003/06/06 GENUS LIFESCIENCES
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 AB4 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 AB4 2006/12/13 MYLAN
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 AB4 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 AB4 2022/05/10 WATSON LABS TEVA
215259 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 AB4 2023/01/18 ASCENT PHARMS INC
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:AB4
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
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 AB4 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 AB4 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 AB4 2003/06/06 GENUS LIFESCIENCES
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 AB4 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 AB4 2022/05/10 WATSON LABS TEVA
215259 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 AB4 2023/01/18 ASCENT PHARMS INC
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:AB4
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
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 AB4 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 AB4 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 AB4 2003/06/06 GENUS LIFESCIENCES
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 AB4 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 AB4 2022/05/10 WATSON LABS TEVA
215259 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 AB4 2023/01/18 ASCENT PHARMS INC
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:AB4
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
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 AB4 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 AB4 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 AB4 2003/06/06 GENUS LIFESCIENCES
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 AB4 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 AB4 2022/05/10 WATSON LABS TEVA
215259 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 AB4 2023/01/18 ASCENT PHARMS INC
活性成分:LEVOTHYROXINE SODIUM 剂型/给药途径:TABLET;ORAL 规格:0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium 治疗等效代码:AB4
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
076187 011 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No Yes AB4 2002/06/05 MYLAN
021116 009 NDA THYRO-TABS LEVOTHYROXINE SODIUM TABLET;ORAL 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes No AB4 2002/10/24 ALVOGEN
021137 012 NDA LEVOLET LEVOTHYROXINE SODIUM TABLET;ORAL 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB4 2003/06/06 GENUS LIFESCIENCES
212399 012 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB4 2020/10/19 ACCORD HLTHCARE
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