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 48215 条，共 2411 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
PRECEF 050554 001 NDA CEFORANIDE INJECTABLE;INJECTION 500MG/VIAL No No 1984/05/24 BRISTOL DISCN 详细信息
PREDNISOLONE ACETATE 083738 001 ANDA PREDNISOLONE ACETATE INJECTABLE;INJECTION 25MG/ML No No Approved Prior to Jan 1, 1982 BEL MAR DISCN 详细信息
PREDNISOLONE ACETATE 083738 002 ANDA PREDNISOLONE ACETATE INJECTABLE;INJECTION 50MG/ML No No Approved Prior to Jan 1, 1982 BEL MAR DISCN 详细信息
PREDNISOLONE ACETATE 084717 001 ANDA PREDNISOLONE ACETATE INJECTABLE;INJECTION 25MG/ML No No Approved Prior to Jan 1, 1982 CENT PHARMS DISCN 详细信息
PREDNISOLONE ACETATE 084717 002 ANDA PREDNISOLONE ACETATE INJECTABLE;INJECTION 50MG/ML No No Approved Prior to Jan 1, 1982 CENT PHARMS DISCN 详细信息
PREDNISOLONE ACETATE 083032 001 ANDA PREDNISOLONE ACETATE INJECTABLE;INJECTION 25MG/ML No No Approved Prior to Jan 1, 1982 EPIC PHARMA LLC DISCN 详细信息
PREDNISOLONE ACETATE 084492 001 ANDA PREDNISOLONE ACETATE INJECTABLE;INJECTION 50MG/ML No No Approved Prior to Jan 1, 1982 EPIC PHARMA LLC DISCN 详细信息
PREDNISOLONE ACETATE 083398 001 ANDA PREDNISOLONE ACETATE INJECTABLE;INJECTION 25MG/ML No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
PREDNISOLONE ACETATE 083654 001 ANDA PREDNISOLONE ACETATE INJECTABLE;INJECTION 25MG/ML No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
PREDNISOLONE ACETATE 083767 001 ANDA PREDNISOLONE ACETATE INJECTABLE;INJECTION 40MG/ML No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
PREDNISOLONE ACETATE 083764 001 ANDA PREDNISOLONE ACETATE INJECTABLE;INJECTION 50MG/ML No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
PREDNISOLONE ACETATE 085781 001 ANDA PREDNISOLONE ACETATE INJECTABLE;INJECTION 50MG/ML No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
PREDNISOLONE SODIUM PHOSPHATE 080517 001 ANDA PREDNISOLONE SODIUM PHOSPHATE INJECTABLE;INJECTION EQ 20MG PHOSPHATE/ML No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
PREDNISOLONE TEBUTATE 083362 001 ANDA PREDNISOLONE TEBUTATE INJECTABLE;INJECTION 20MG/ML No No 1984/02/17 WATSON LABS DISCN 详细信息
PREMARIN 010402 001 NDA ESTROGENS, CONJUGATED INJECTABLE;INJECTION 25MG/VIAL Yes Yes Approved Prior to Jan 1, 1982 WYETH PHARMS RX 详细信息
PREMASOL 10% IN PLASTIC CONTAINER 075880 002 ANDA AMINO ACIDS INJECTABLE;INJECTION 10% (10GM/100ML) No No 2003/06/19 BAXTER HLTHCARE RX 详细信息
PREMASOL 6% IN PLASTIC CONTAINER 075880 001 ANDA AMINO ACIDS INJECTABLE;INJECTION 6% (6GM/100ML) No No 2003/06/19 BAXTER HLTHCARE RX 详细信息
PRILOCAINE HYDROCHLORIDE 079235 001 ANDA PRILOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 4% No Yes 2010/09/29 SEPTODONT INC RX 详细信息
PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE 078959 001 ANDA EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.005MG/ML;4% No No AP 2011/08/30 SEPTODONT INC RX 详细信息
PRIMACOR 019436 001 NDA MILRINONE LACTATE INJECTABLE;INJECTION EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1987/12/31 SANOFI AVENTIS US DISCN 详细信息
当前数据更新日期：2026年05月28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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