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 83 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
PENTOBARBITAL SODIUM 083284 001 ANDA PENTOBARBITAL SODIUM CAPSULE;ORAL 100MG No No Approved Prior to Jan 1, 1982 VITARINE DISCN 详细信息
PENTOBARBITAL SODIUM 083338 001 ANDA PENTOBARBITAL SODIUM CAPSULE;ORAL 100MG No No Approved Prior to Jan 1, 1982 WHITEWORTH TOWN PLSN DISCN 详细信息
PERCHLORACAP 017551 001 NDA POTASSIUM PERCHLORATE CAPSULE;ORAL 200MG No No Approved Prior to Jan 1, 1982 MALLINCKRODT DISCN 详细信息
PERIOSTAT 050744 001 NDA DOXYCYCLINE HYCLATE CAPSULE;ORAL EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1998/09/30 COLLAGENEX DISCN 详细信息
PERTOFRANE 013621 001 NDA DESIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 25MG No No Approved Prior to Jan 1, 1982 SANOFI AVENTIS US DISCN 详细信息
PERTOFRANE 013621 002 NDA DESIPRAMINE HYDROCHLORIDE CAPSULE;ORAL 50MG No No Approved Prior to Jan 1, 1982 SANOFI AVENTIS US DISCN 详细信息
PFIZERPEN-A 062050 001 ANDA AMPICILLIN/AMPICILLIN TRIHYDRATE CAPSULE;ORAL EQ 250MG BASE No No Approved Prior to Jan 1, 1982 PFIZER DISCN 详细信息
PFIZERPEN-A 062050 002 ANDA AMPICILLIN/AMPICILLIN TRIHYDRATE CAPSULE;ORAL EQ 500MG BASE No No Approved Prior to Jan 1, 1982 PFIZER DISCN 详细信息
PHENAPHEN W/ CODEINE NO. 2 084444 001 ANDA ACETAMINOPHEN; CODEINE PHOSPHATE CAPSULE;ORAL 325MG;15MG No No Approved Prior to Jan 1, 1982 ROBINS AH DISCN 详细信息
PHENAPHEN W/ CODEINE NO. 3 084445 001 ANDA ACETAMINOPHEN; CODEINE PHOSPHATE CAPSULE;ORAL 325MG;30MG Yes No Approved Prior to Jan 1, 1982 ROBINS AH DISCN 详细信息
PHENAPHEN W/ CODEINE NO. 4 084446 001 ANDA ACETAMINOPHEN; CODEINE PHOSPHATE CAPSULE;ORAL 325MG;60MG Yes No Approved Prior to Jan 1, 1982 ROBINS AH DISCN 详细信息
PHENAZINE 086523 001 ANDA PHENDIMETRAZINE TARTRATE CAPSULE;ORAL 35MG No No Approved Prior to Jan 1, 1982 MAST MM DISCN 详细信息
PHENAZINE 086524 001 ANDA PHENDIMETRAZINE TARTRATE CAPSULE;ORAL 35MG No No Approved Prior to Jan 1, 1982 MAST MM DISCN 详细信息
PHENAZINE 086525 001 ANDA PHENDIMETRAZINE TARTRATE CAPSULE;ORAL 35MG No No Approved Prior to Jan 1, 1982 MAST MM DISCN 详细信息
PHENDIMETRAZINE TARTRATE 085633 001 ANDA PHENDIMETRAZINE TARTRATE CAPSULE;ORAL 35MG No No Approved Prior to Jan 1, 1982 SANDOZ DISCN 详细信息
PHENDIMETRAZINE TARTRATE 085694 001 ANDA PHENDIMETRAZINE TARTRATE CAPSULE;ORAL 35MG No No Approved Prior to Jan 1, 1982 SANDOZ DISCN 详细信息
PHENDIMETRAZINE TARTRATE 085702 001 ANDA PHENDIMETRAZINE TARTRATE CAPSULE;ORAL 35MG No No Approved Prior to Jan 1, 1982 SANDOZ DISCN 详细信息
PHENDIMETRAZINE TARTRATE 085695 001 ANDA PHENDIMETRAZINE TARTRATE CAPSULE;ORAL 35MG No No Approved Prior to Jan 1, 1982 VIRTUS DISCN 详细信息
PHENDIMETRAZINE TARTRATE 085634 001 ANDA PHENDIMETRAZINE TARTRATE CAPSULE;ORAL 35MG No No Approved Prior to Jan 1, 1982 VITARINE DISCN 详细信息
PHENDIMETRAZINE TARTRATE 085645 001 ANDA PHENDIMETRAZINE TARTRATE CAPSULE;ORAL 35MG No No Approved Prior to Jan 1, 1982 VITARINE 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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