美国FDA药品橙皮书数据库
（U.S. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations）
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数据记录共 47588 条，共 2380 页，当前第 82 页
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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
PAROXETINE MESYLATE 207188 001 ANDA PAROXETINE MESYLATE CAPSULE;ORAL EQ 7.5MG BASE No No AB 2017/08/18 PRINSTON INC RX 详细信息
PASKALIUM 009395 004 NDA POTASSIUM AMINOSALICYLATE CAPSULE;ORAL 500MG No No Approved Prior to Jan 1, 1982 GLENWOOD DISCN 详细信息
PATHOCIL 050011 002 NDA DICLOXACILLIN SODIUM CAPSULE;ORAL EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 WYETH AYERST DISCN 详细信息
PATHOCIL 050011 003 NDA DICLOXACILLIN SODIUM CAPSULE;ORAL EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1983/03/28 WYETH AYERST DISCN 详细信息
PAXIL 020885 001 NDA PAROXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1998/10/09 APOTEX DISCN 详细信息
PAXIL 020885 002 NDA PAROXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1998/10/09 APOTEX DISCN 详细信息
PAXIL 020885 003 NDA PAROXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 30MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1998/10/09 APOTEX DISCN 详细信息
PAXIL 020885 004 NDA PAROXETINE HYDROCHLORIDE CAPSULE;ORAL EQ 40MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1998/10/09 APOTEX DISCN 详细信息
PENBRITIN 060908 001 ANDA AMPICILLIN/AMPICILLIN TRIHYDRATE CAPSULE;ORAL EQ 250MG BASE No No Approved Prior to Jan 1, 1982 WYETH AYERST DISCN 详细信息
PENBRITIN 060908 002 ANDA AMPICILLIN/AMPICILLIN TRIHYDRATE CAPSULE;ORAL EQ 500MG BASE No No Approved Prior to Jan 1, 1982 WYETH AYERST DISCN 详细信息
PENICILLAMINE 213310 001 ANDA PENICILLAMINE CAPSULE;ORAL 250MG No No 2020/04/28 APOTEX DISCN 详细信息
PENICILLAMINE 215409 001 ANDA PENICILLAMINE CAPSULE;ORAL 250MG No No AB 2021/08/23 BRECKENRIDGE RX 详细信息
PENICILLAMINE 211867 001 ANDA PENICILLAMINE CAPSULE;ORAL 250MG No No AB 2020/08/04 DR REDDYS RX 详细信息
PENICILLAMINE 211735 001 ANDA PENICILLAMINE CAPSULE;ORAL 250MG No No AB 2020/12/02 GRANULES RX 详细信息
PENICILLAMINE 213293 001 ANDA PENICILLAMINE CAPSULE;ORAL 250MG No No AB 2021/08/19 INVAGEN PHARMS RX 详细信息
PENICILLAMINE 214363 001 ANDA PENICILLAMINE CAPSULE;ORAL 250MG No No AB 2021/10/08 NAVINTA LLC RX 详细信息
PENICILLAMINE 211231 001 ANDA PENICILLAMINE CAPSULE;ORAL 250MG No No AB 2019/12/23 PH HEALTH RX 详细信息
PENICILLAMINE 210976 001 ANDA PENICILLAMINE CAPSULE;ORAL 250MG No No AB 2019/06/24 WATSON LABS INC RX 详细信息
PENTOBARBITAL SODIUM 085937 001 ANDA PENTOBARBITAL SODIUM CAPSULE;ORAL 50MG No No Approved Prior to Jan 1, 1982 LANNETT DISCN 详细信息
PENTOBARBITAL SODIUM 085915 001 ANDA PENTOBARBITAL SODIUM CAPSULE;ORAL 100MG No No Approved Prior to Jan 1, 1982 LANNETT DISCN 详细信息
当前数据更新日期：2026年02月10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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