美国FDA药品橙皮书数据库
(U.S. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations)
商品名 申请号 产品号 申请类型 活性成分 剂型/给药途径 规格/剂量 是否参比药物 是否生物等效参考标准 治疗等效代码 产品批准日期 申请人 市场状态 专利及市场独占权
GLIPIZIDE AND METFORMIN HYDROCHLORIDE 077270 003 ANDA GLIPIZIDE; METFORMIN HYDROCHLORIDE TABLET;ORAL 5MG;500MG No Yes AB 2005/10/28 TEVA PHARMS RX 详细信息
GLIPIZIDE AND METFORMIN HYDROCHLORIDE 078905 001 ANDA GLIPIZIDE; METFORMIN HYDROCHLORIDE TABLET;ORAL 2.5MG;250MG No No AB 2011/01/31 ZYDUS PHARMS USA INC RX 详细信息
GLIPIZIDE AND METFORMIN HYDROCHLORIDE 078905 002 ANDA GLIPIZIDE; METFORMIN HYDROCHLORIDE TABLET;ORAL 2.5MG;500MG No No AB 2011/01/31 ZYDUS PHARMS USA INC RX 详细信息
GLIPIZIDE AND METFORMIN HYDROCHLORIDE 078905 003 ANDA GLIPIZIDE; METFORMIN HYDROCHLORIDE TABLET;ORAL 5MG;500MG No No AB 2011/01/31 ZYDUS PHARMS USA INC RX 详细信息
GLUCAMIDE 088641 001 ANDA CHLORPROPAMIDE TABLET;ORAL 250MG No No 1984/10/11 ANI PHARMS DISCN 详细信息
GLUCOPHAGE 020357 005 NDA METFORMIN HYDROCHLORIDE TABLET;ORAL 1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1998/11/05 EMD SERONO INC DISCN 详细信息
GLUCOPHAGE 020357 001 NDA METFORMIN HYDROCHLORIDE TABLET;ORAL 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1995/03/03 EMD SERONO INC DISCN 详细信息
GLUCOPHAGE 020357 003 NDA METFORMIN HYDROCHLORIDE TABLET;ORAL 625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1998/11/05 EMD SERONO INC DISCN 详细信息
GLUCOPHAGE 020357 004 NDA METFORMIN HYDROCHLORIDE TABLET;ORAL 750MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1998/11/05 EMD SERONO INC DISCN 详细信息
GLUCOPHAGE 020357 002 NDA METFORMIN HYDROCHLORIDE TABLET;ORAL 850MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1995/03/03 EMD SERONO INC DISCN 详细信息
GLUCOTROL 017783 003 NDA GLIPIZIDE TABLET;ORAL 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1993/05/11 PFIZER DISCN 详细信息
GLUCOTROL 017783 001 NDA GLIPIZIDE TABLET;ORAL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1984/05/08 PFIZER DISCN 详细信息
GLUCOTROL 017783 002 NDA GLIPIZIDE TABLET;ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1984/05/08 PFIZER DISCN 详细信息
GLUCOVANCE 021178 001 NDA GLYBURIDE; METFORMIN HYDROCHLORIDE TABLET;ORAL 1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2000/07/31 BRISTOL MYERS SQUIBB DISCN 详细信息
GLUCOVANCE 021178 002 NDA GLYBURIDE; METFORMIN HYDROCHLORIDE TABLET;ORAL 2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2000/07/31 BRISTOL MYERS SQUIBB DISCN 详细信息
GLUCOVANCE 021178 003 NDA GLYBURIDE; METFORMIN HYDROCHLORIDE TABLET;ORAL 5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2000/07/31 BRISTOL MYERS SQUIBB DISCN 详细信息
GLUTETHIMIDE 089458 001 ANDA GLUTETHIMIDE TABLET;ORAL 250MG No No 1986/10/10 HALSEY DISCN 详细信息
GLUTETHIMIDE 089459 001 ANDA GLUTETHIMIDE TABLET;ORAL 500MG No No 1986/10/10 HALSEY DISCN 详细信息
GLUTETHIMIDE 083475 001 ANDA GLUTETHIMIDE TABLET;ORAL 250MG No No Approved Prior to Jan 1, 1982 LANNETT DISCN 详细信息
GLUTETHIMIDE 085571 001 ANDA GLUTETHIMIDE TABLET;ORAL 500MG No No Approved Prior to Jan 1, 1982 LANNETT DISCN 详细信息
当前数据更新日期:2025年12月09日,更多信息请点击此处查询美国FDA药品数据库
数据库说明:本数据与美国FDA官方药品橙皮书数据库同步,在官方数据基础上,提供更全面的检索方式和更简洁高效、完整的数据展现,并且可以回溯专利及市场独占权(市场排他数据)历史信息。
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