药品注册申请号:074223
申请类型:ANDA (仿制药申请)
申请人:WATSON LABS TEVA
申请人全名:WATSON LABORATORIES INC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA 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 GLIPIZIDE GLIPIZIDE TABLET;ORAL 5MG No No AB 1995/02/27 1995/02/27 Prescription
002 GLIPIZIDE GLIPIZIDE TABLET;ORAL 10MG No No AB 1995/02/27 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
2021/05/16 SUPPL-19(补充) Approval Labeling STANDARD
2016/01/05 SUPPL-17(补充) Approval Labeling STANDARD
2013/07/26 SUPPL-16(补充) Approval Labeling STANDARD
2002/06/17 SUPPL-7(补充) Approval Manufacturing (CMC)
2002/06/13 SUPPL-8(补充) Approval Manufacturing (CMC)
2001/09/25 SUPPL-6(补充) Approval Labeling
2001/09/05 SUPPL-5(补充) Approval Manufacturing (CMC)
2000/07/13 SUPPL-1(补充) Approval Manufacturing (CMC)
2000/01/20 SUPPL-4(补充) Approval Labeling
1999/11/10 SUPPL-2(补充) Approval Manufacturing (CMC)
1999/11/05 SUPPL-3(补充) Approval Manufacturing (CMC)
1995/02/27 ORIG-1(原始申请) Approval
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
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
与本品治疗等效的药品
活性成分:GLIPIZIDE 剂型/给药途径:TABLET;ORAL 规格:5MG 治疗等效代码:AB
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
074226 001 ANDA GLIPIZIDE GLIPIZIDE TABLET;ORAL 5MG Prescription No No AB 1994/05/10 AUROBINDO PHARMA USA
074223 001 ANDA GLIPIZIDE GLIPIZIDE TABLET;ORAL 5MG Prescription No No AB 1995/02/27 WATSON LABS TEVA
074305 001 ANDA GLIPIZIDE GLIPIZIDE TABLET;ORAL 5MG Discontinued No No AB 1995/04/07 SANDOZ
074497 001 ANDA GLIPIZIDE GLIPIZIDE TABLET;ORAL 5MG Prescription No No AB 1995/08/31 ANI PHARMS
074550 001 ANDA GLIPIZIDE GLIPIZIDE TABLET;ORAL 5MG Discontinued No No AB 1997/09/11 ACCORD HLTHCARE
075795 001 ANDA GLIPIZIDE GLIPIZIDE TABLET;ORAL 5MG Prescription No No AB 2001/06/13 APOTEX
077820 001 ANDA GLIPIZIDE GLIPIZIDE TABLET;ORAL 5MG Discontinued No No AB 2006/07/11 SUN PHARM INDS INC
214874 002 ANDA GLIPIZIDE GLIPIZIDE TABLET;ORAL 5MG Prescription No No AB 2023/10/03 RUBICON
活性成分:GLIPIZIDE 剂型/给药途径:TABLET;ORAL 规格:10MG 治疗等效代码:AB
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
074226 002 ANDA GLIPIZIDE GLIPIZIDE TABLET;ORAL 10MG Prescription No No AB 1994/05/10 AUROBINDO PHARMA USA
074223 002 ANDA GLIPIZIDE GLIPIZIDE TABLET;ORAL 10MG Prescription No No AB 1995/02/27 WATSON LABS TEVA
074305 002 ANDA GLIPIZIDE GLIPIZIDE TABLET;ORAL 10MG Discontinued No No AB 1995/04/07 SANDOZ
074497 002 ANDA GLIPIZIDE GLIPIZIDE TABLET;ORAL 10MG Prescription No No AB 1995/08/31 ANI PHARMS
074550 002 ANDA GLIPIZIDE GLIPIZIDE TABLET;ORAL 10MG Discontinued No No AB 1997/09/11 ACCORD HLTHCARE
075795 002 ANDA GLIPIZIDE GLIPIZIDE TABLET;ORAL 10MG Prescription No Yes AB 2001/06/13 APOTEX
077820 002 ANDA GLIPIZIDE GLIPIZIDE TABLET;ORAL 10MG Discontinued No No AB 2006/07/11 SUN PHARM INDS INC
214874 003 ANDA GLIPIZIDE GLIPIZIDE TABLET;ORAL 10MG Prescription No No AB 2023/10/03 RUBICON
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