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
HER STYLE 207976 001 ANDA LEVONORGESTREL TABLET;ORAL 1.5MG No No 2016/03/11 NOVAST LABS OTC 详细信息
HETRAZAN 006459 001 NDA DIETHYLCARBAMAZINE CITRATE TABLET;ORAL 50MG No No Approved Prior to Jan 1, 1982 LEDERLE DISCN 详细信息
HEXADROL 012675 004 NDA DEXAMETHASONE TABLET;ORAL 0.5MG No No Approved Prior to Jan 1, 1982 ASPEN GLOBAL INC DISCN 详细信息
HEXADROL 012675 007 NDA DEXAMETHASONE TABLET;ORAL 0.75MG No No Approved Prior to Jan 1, 1982 ASPEN GLOBAL INC DISCN 详细信息
HEXADROL 012675 009 NDA DEXAMETHASONE TABLET;ORAL 1.5MG No No Approved Prior to Jan 1, 1982 ASPEN GLOBAL INC DISCN 详细信息
HEXADROL 012675 010 NDA DEXAMETHASONE TABLET;ORAL 4MG No No Approved Prior to Jan 1, 1982 ASPEN GLOBAL INC DISCN 详细信息
HIPREX 017681 001 NDA METHENAMINE HIPPURATE TABLET;ORAL 1GM Yes Yes AB Approved Prior to Jan 1, 1982 US PHARM HOLDINGS RX 详细信息
HISERPIA 009631 002 NDA RESERPINE TABLET;ORAL 0.1MG No No Approved Prior to Jan 1, 1982 BOWMAN PHARMS DISCN 详细信息
HISERPIA 009631 004 NDA RESERPINE TABLET;ORAL 0.25MG No No Approved Prior to Jan 1, 1982 BOWMAN PHARMS DISCN 详细信息
HIVID 020199 001 NDA ZALCITABINE TABLET;ORAL 0.375MG No No 1992/06/19 ROCHE DISCN 详细信息
HIVID 020199 002 NDA ZALCITABINE TABLET;ORAL 0.75MG No No 1992/06/19 ROCHE DISCN 详细信息
HIWOLFIA 009276 003 NDA RAUWOLFIA SERPENTINA ROOT TABLET;ORAL 50MG No No Approved Prior to Jan 1, 1982 BOWMAN PHARMS DISCN 详细信息
HIWOLFIA 009276 005 NDA RAUWOLFIA SERPENTINA ROOT TABLET;ORAL 50MG No No Approved Prior to Jan 1, 1982 BOWMAN PHARMS DISCN 详细信息
HIWOLFIA 009276 004 NDA RAUWOLFIA SERPENTINA ROOT TABLET;ORAL 100MG No No Approved Prior to Jan 1, 1982 BOWMAN PHARMS DISCN 详细信息
HOMAPIN-10 086308 001 ANDA HOMATROPINE METHYLBROMIDE TABLET;ORAL 10MG No No Approved Prior to Jan 1, 1982 MISSION PHARMA DISCN 详细信息
HOMAPIN-5 086309 001 ANDA HOMATROPINE METHYLBROMIDE TABLET;ORAL 5MG No No Approved Prior to Jan 1, 1982 MISSION PHARMA DISCN 详细信息
HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 040295 001 ANDA HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE TABLET;ORAL 1.5MG;5MG No No 2000/12/01 ACTAVIS ELIZABETH DISCN 详细信息
HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 207176 001 ANDA HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE TABLET;ORAL 1.5MG;5MG No No AA 2017/08/07 AVANTHI INC RX 详细信息
HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE 091528 001 ANDA HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE TABLET;ORAL 1.5MG;5MG No No AA 2011/04/20 NOVEL LABS INC RX 详细信息
HY-PHEN 087677 001 ANDA ACETAMINOPHEN; HYDROCODONE BITARTRATE TABLET;ORAL 500MG;5MG No No 1982/05/03 ASCHER DISCN 详细信息
当前数据更新日期:2019年08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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