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 88 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
PROGRAF 050709 001 NDA TACROLIMUS INJECTABLE;INJECTION EQ 5MG BASE/ML Yes Yes AP 1994/04/08 ASTELLAS RX 详细信息
PROHANCE 020131 001 NDA GADOTERIDOL INJECTABLE;INJECTION 279.3MG/ML Yes Yes AP 1992/11/16 BRACCO RX 详细信息
PROHANCE MULTIPACK 021489 001 NDA GADOTERIDOL INJECTABLE;INJECTION 279.3MG/ML Yes Yes 2003/10/09 BRACCO RX 详细信息
PROLIXIN 011751 005 NDA FLUPHENAZINE HYDROCHLORIDE INJECTABLE;INJECTION 2.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No Approved Prior to Jan 1, 1982 APOTHECON DISCN 详细信息
PROLIXIN DECANOATE 016727 001 NDA FLUPHENAZINE DECANOATE INJECTABLE;INJECTION 25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 BRISTOL MYERS SQUIBB DISCN 详细信息
PROLIXIN ENANTHATE 016110 001 NDA FLUPHENAZINE ENANTHATE INJECTABLE;INJECTION 25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** No No Approved Prior to Jan 1, 1982 APOTHECON DISCN 详细信息
PROMAZINE HYDROCHLORIDE 084510 001 ANDA PROMAZINE HYDROCHLORIDE INJECTABLE;INJECTION 25MG/ML No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
PROMAZINE HYDROCHLORIDE 084517 001 ANDA PROMAZINE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
PROMETHAZINE HYDROCHLORIDE 084223 001 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 25MG/ML No No Approved Prior to Jan 1, 1982 ABBOTT DISCN 详细信息
PROMETHAZINE HYDROCHLORIDE 084222 001 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML No No Approved Prior to Jan 1, 1982 ABBOTT DISCN 详细信息
PROMETHAZINE HYDROCHLORIDE 040515 001 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 25MG/ML No No 2003/03/19 AM REGENT DISCN 详细信息
PROMETHAZINE HYDROCHLORIDE 040524 001 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 25MG/ML No No 2004/03/17 BEDFORD LABS DISCN 详细信息
PROMETHAZINE HYDROCHLORIDE 040524 002 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML No No 2004/03/17 BEDFORD LABS DISCN 详细信息
PROMETHAZINE HYDROCHLORIDE 083955 002 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 25MG/ML No No Approved Prior to Jan 1, 1982 EPIC PHARMA LLC DISCN 详细信息
PROMETHAZINE HYDROCHLORIDE 083955 001 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML No No Approved Prior to Jan 1, 1982 EPIC PHARMA LLC DISCN 详细信息
PROMETHAZINE HYDROCHLORIDE 083312 001 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 25MG/ML Yes Yes AP Approved Prior to Jan 1, 1982 HIKMA RX 详细信息
PROMETHAZINE HYDROCHLORIDE 083312 002 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML Yes Yes AP Approved Prior to Jan 1, 1982 HIKMA RX 详细信息
PROMETHAZINE HYDROCHLORIDE 040372 001 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 25MG/ML No No 2000/06/08 HOSPIRA DISCN 详细信息
PROMETHAZINE HYDROCHLORIDE 040372 002 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML No No 2000/06/08 HOSPIRA DISCN 详细信息
PROMETHAZINE HYDROCHLORIDE 083838 002 ANDA PROMETHAZINE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML No No Approved Prior to Jan 1, 1982 HOSPIRA DISCN 详细信息
当前数据更新日期：2026年06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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