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 91 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
PURIFIED CORTROPHIN GEL 008975 001 NDA CORTICOTROPIN INJECTABLE;INJECTION 40 UNITS/ML No No Approved Prior to Jan 1, 1982 ANI PHARMS DISCN 详细信息
PURIFIED CORTROPHIN GEL 008975 002 NDA CORTICOTROPIN INJECTABLE;INJECTION 80 UNITS/ML Yes Yes Approved Prior to Jan 1, 1982 ANI PHARMS RX 详细信息
PYOPEN 050298 001 NDA CARBENICILLIN DISODIUM INJECTABLE;INJECTION EQ 1GM BASE/VIAL No No Approved Prior to Jan 1, 1982 GLAXOSMITHKLINE DISCN 详细信息
PYOPEN 050298 002 NDA CARBENICILLIN DISODIUM INJECTABLE;INJECTION EQ 2GM BASE/VIAL No No Approved Prior to Jan 1, 1982 GLAXOSMITHKLINE DISCN 详细信息
PYOPEN 050298 003 NDA CARBENICILLIN DISODIUM INJECTABLE;INJECTION EQ 5GM BASE/VIAL No No Approved Prior to Jan 1, 1982 GLAXOSMITHKLINE DISCN 详细信息
PYOPEN 050298 006 NDA CARBENICILLIN DISODIUM INJECTABLE;INJECTION EQ 10GM BASE/VIAL No No Approved Prior to Jan 1, 1982 GLAXOSMITHKLINE DISCN 详细信息
PYOPEN 050298 007 NDA CARBENICILLIN DISODIUM INJECTABLE;INJECTION EQ 20GM BASE/VIAL No No Approved Prior to Jan 1, 1982 GLAXOSMITHKLINE DISCN 详细信息
PYRIDAMAL 100 083733 001 ANDA CHLORPHENIRAMINE MALEATE INJECTABLE;INJECTION 100MG/ML No No Approved Prior to Jan 1, 1982 BEL MAR DISCN 详细信息
PYRIDOXINE HYDROCHLORIDE 080761 001 ANDA PYRIDOXINE HYDROCHLORIDE INJECTABLE;INJECTION 100MG/ML No No Approved Prior to Jan 1, 1982 BEL MAR DISCN 详细信息
PYRIDOXINE HYDROCHLORIDE 083771 001 ANDA PYRIDOXINE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML No No Approved Prior to Jan 1, 1982 DELL LABS DISCN 详细信息
PYRIDOXINE HYDROCHLORIDE 083772 001 ANDA PYRIDOXINE HYDROCHLORIDE INJECTABLE;INJECTION 100MG/ML No No Approved Prior to Jan 1, 1982 DELL LABS DISCN 详细信息
PYRIDOXINE HYDROCHLORIDE 080572 001 ANDA PYRIDOXINE HYDROCHLORIDE INJECTABLE;INJECTION 100MG/ML No No Approved Prior to Jan 1, 1982 DR REDDYS DISCN 详细信息
PYRIDOXINE HYDROCHLORIDE 080581 001 ANDA PYRIDOXINE HYDROCHLORIDE INJECTABLE;INJECTION 100MG/ML No No Approved Prior to Jan 1, 1982 ELKINS SINN DISCN 详细信息
PYRIDOXINE HYDROCHLORIDE 087967 001 ANDA PYRIDOXINE HYDROCHLORIDE INJECTABLE;INJECTION 100MG/ML No No 1982/10/01 EPIC PHARMA LLC DISCN 详细信息
PYRIDOXINE HYDROCHLORIDE 080618 001 ANDA PYRIDOXINE HYDROCHLORIDE INJECTABLE;INJECTION 100MG/ML Yes Yes Approved Prior to Jan 1, 1982 FRESENIUS KABI USA RX 详细信息
PYRIDOXINE HYDROCHLORIDE 080669 001 ANDA PYRIDOXINE HYDROCHLORIDE INJECTABLE;INJECTION 100MG/ML No No Approved Prior to Jan 1, 1982 LUITPOLD DISCN 详细信息
PYRIDOXINE HYDROCHLORIDE 204879 001 ANDA PYRIDOXINE HYDROCHLORIDE INJECTABLE;INJECTION 100MG/ML No No 2016/07/14 MYLAN INSTITUTIONAL DISCN 详细信息
PYRIDOXINE HYDROCHLORIDE 083760 001 ANDA PYRIDOXINE HYDROCHLORIDE INJECTABLE;INJECTION 100MG/ML No No Approved Prior to Jan 1, 1982 WATSON LABS DISCN 详细信息
PYROLITE 017684 001 NDA TECHNETIUM TC-99M PYRO/TRIMETA PHOSPHATES KIT INJECTABLE;INJECTION N/A No No Approved Prior to Jan 1, 1982 PHARMALUCENCE DISCN 详细信息
QUADRAMET 020570 001 NDA SAMARIUM SM-153 LEXIDRONAM PENTASODIUM INJECTABLE;INJECTION 50mCi/ML Yes No 1997/03/28 LANTHEUS MEDICAL 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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