药品注册申请号：216414
申请类型：ANDA (仿制药申请)
申请人：AUROBINDO PHARMA
申请人全名：AUROBINDO PHARMA LTD
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 0.137MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium No No AB2 2024/07/16 2024/07/16 Prescription
002 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.15MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium No No AB2 2024/07/16 Prescription
003 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.175MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium No No AB2 2024/07/16 Prescription
004 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.2MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium No No AB2 2024/07/16 Prescription
005 LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium No No AB2 2024/07/16 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
2024/07/16 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:0.137MG **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
216414 001 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 2024/07/16 AUROBINDO PHARMA
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
216414 002 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 2024/07/16 AUROBINDO PHARMA
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
216414 003 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 2024/07/16 AUROBINDO PHARMA
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
216414 004 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 2024/07/16 AUROBINDO PHARMA
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: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 011 NDA UNITHROID LEVOTHYROXINE SODIUM TABLET;ORAL 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes Yes AB2 2000/08/21 STEVENS J
021342 011 NDA LEVO-T LEVOTHYROXINE SODIUM TABLET;ORAL 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB2 2002/03/01 CEDIPROF INC
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 AB2 2002/06/05 MYLAN
021402 011 NDA SYNTHROID LEVOTHYROXINE SODIUM TABLET;ORAL 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription Yes Yes AB2 2002/07/24 ABBVIE
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 AB2 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 AB2 2003/06/06 GENUS LIFESCIENCES
209713 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 AB2 2019/01/18 LUPIN
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 AB2 2020/10/19 ACCORD HLTHCARE
207588 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 AB2 2022/05/10 WATSON LABS TEVA
211417 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 AB2 2022/12/21 MACLEODS PHARMS LTD
216414 005 ANDA LEVOTHYROXINE SODIUM LEVOTHYROXINE SODIUM TABLET;ORAL 0.3MG **See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium Prescription No No AB2 2024/07/16 AUROBINDO PHARMA
更多信息
药品NDC数据与药品包装、标签说明书
参考引用1
参考引用2
©2006-2024 DrugFuture->U.S. FDA Drugs Database