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 42846 条，共 2143 页，当前第 2 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
DELESTROGEN 009402 003 NDA ESTRADIOL VALERATE INJECTABLE;INJECTION 40MG/ML Yes Yes AO Approved Prior to Jan 1, 1982 PAR STERILE PRODUCTS RX 详细信息
DEMADEX 020137 002 NDA TORSEMIDE INJECTABLE;INJECTION 50MG/5ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1993/08/23 ROCHE DISCN 详细信息
DEMADEX 020137 001 NDA TORSEMIDE INJECTABLE;INJECTION 20MG/2ML (10MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1993/08/23 ROCHE DISCN 详细信息
DEMEROL 021171 001 NDA MEPERIDINE HYDROCHLORIDE INJECTABLE;INJECTION 25MG/ML Yes Yes AP Approved Prior to Jan 1, 1982 HOSPIRA RX 详细信息
DEMEROL 021171 002 NDA MEPERIDINE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML Yes Yes AP Approved Prior to Jan 1, 1982 HOSPIRA RX 详细信息
DEMEROL 021171 003 NDA MEPERIDINE HYDROCHLORIDE INJECTABLE;INJECTION 75MG/ML Yes Yes AP Approved Prior to Jan 1, 1982 HOSPIRA RX 详细信息
DEMEROL 021171 004 NDA MEPERIDINE HYDROCHLORIDE INJECTABLE;INJECTION 100MG/ML Yes Yes AP Approved Prior to Jan 1, 1982 HOSPIRA RX 详细信息
DEMEROL 005010 007 NDA MEPERIDINE HYDROCHLORIDE INJECTABLE;INJECTION 25MG/ML No No Approved Prior to Jan 1, 1982 VALIDUS PHARMS DISCN 详细信息
DEMEROL 005010 002 NDA MEPERIDINE HYDROCHLORIDE INJECTABLE;INJECTION 50MG/ML No No Approved Prior to Jan 1, 1982 VALIDUS PHARMS DISCN 详细信息
DEMEROL 005010 009 NDA MEPERIDINE HYDROCHLORIDE INJECTABLE;INJECTION 75MG/ML No No Approved Prior to Jan 1, 1982 VALIDUS PHARMS DISCN 详细信息
DEMEROL 005010 003 NDA MEPERIDINE HYDROCHLORIDE INJECTABLE;INJECTION 100MG/ML No No Approved Prior to Jan 1, 1982 VALIDUS PHARMS DISCN 详细信息
DEPACON 020593 001 NDA VALPROATE SODIUM INJECTABLE;INJECTION EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1996/12/30 ABBVIE DISCN 详细信息
DEPINAR 011208 001 NDA CYANOCOBALAMIN; TANNIC ACID; ZINC ACETATE INJECTABLE;INJECTION 0.5MG/ML;2.3MG/ML;1MG/ML No No Approved Prior to Jan 1, 1982 ARMOUR PHARM DISCN 详细信息
DEPO-ESTRADIOL 085470 001 ANDA ESTRADIOL CYPIONATE INJECTABLE;INJECTION 1MG/ML No No Approved Prior to Jan 1, 1982 PFIZER DISCN 详细信息
DEPO-ESTRADIOL 085470 002 ANDA ESTRADIOL CYPIONATE INJECTABLE;INJECTION 3MG/ML No No Approved Prior to Jan 1, 1982 PFIZER DISCN 详细信息
DEPO-ESTRADIOL 085470 003 ANDA ESTRADIOL CYPIONATE INJECTABLE;INJECTION 5MG/ML No Yes Approved Prior to Jan 1, 1982 PFIZER RX 详细信息
DEPO-MEDROL 011757 002 NDA METHYLPREDNISOLONE ACETATE INJECTABLE;INJECTION 20MG/ML Yes Yes Approved Prior to Jan 1, 1982 PFIZER RX 详细信息
DEPO-MEDROL 011757 001 NDA METHYLPREDNISOLONE ACETATE INJECTABLE;INJECTION 40MG/ML Yes No AB Approved Prior to Jan 1, 1982 PFIZER RX 详细信息
DEPO-MEDROL 011757 004 NDA METHYLPREDNISOLONE ACETATE INJECTABLE;INJECTION 80MG/ML Yes No AB Approved Prior to Jan 1, 1982 PFIZER RX 详细信息
DEPO-PROVERA 012541 002 NDA MEDROXYPROGESTERONE ACETATE INJECTABLE;INJECTION 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 PFIZER DISCN 详细信息
当前数据更新日期：2023年03月30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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