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 1 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
DECA-DURABOLIN 013132 002 NDA NANDROLONE DECANOATE INJECTABLE;INJECTION 100MG/ML No No 1986/06/12 WOODWARD SPECL DISCN 详细信息
DECA-DURABOLIN 013132 003 NDA NANDROLONE DECANOATE INJECTABLE;INJECTION 200MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1986/06/12 WOODWARD SPECL DISCN 详细信息
DECADRON 012071 002 NDA DEXAMETHASONE SODIUM PHOSPHATE INJECTABLE;INJECTION EQ 4MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 MERCK DISCN 详细信息
DECADRON 012071 004 NDA DEXAMETHASONE SODIUM PHOSPHATE INJECTABLE;INJECTION EQ 24MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 MERCK DISCN 详细信息
DECADRON W/ XYLOCAINE 013334 002 NDA DEXAMETHASONE SODIUM PHOSPHATE; LIDOCAINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 4MG PHOSPHATE/ML;10MG/ML No No Approved Prior to Jan 1, 1982 MERCK DISCN 详细信息
DECADRON-LA 016675 001 NDA DEXAMETHASONE ACETATE INJECTABLE;INJECTION EQ 8MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No Approved Prior to Jan 1, 1982 MERCK DISCN 详细信息
DEFEROXAMINE MESYLATE 076806 002 ANDA DEFEROXAMINE MESYLATE INJECTABLE;INJECTION 2GM/VIAL No No 2006/03/31 DR REDDYS DISCN 详细信息
DEFEROXAMINE MESYLATE 076806 001 ANDA DEFEROXAMINE MESYLATE INJECTABLE;INJECTION 500MG/VIAL No No 2006/03/31 DR REDDYS DISCN 详细信息
DEFEROXAMINE MESYLATE 078718 002 ANDA DEFEROXAMINE MESYLATE INJECTABLE;INJECTION 2GM/VIAL No No AP 2009/09/15 FRESENIUS KABI USA RX 详细信息
DEFEROXAMINE MESYLATE 078718 001 ANDA DEFEROXAMINE MESYLATE INJECTABLE;INJECTION 500MG/VIAL No No AP 2009/09/15 FRESENIUS KABI USA RX 详细信息
DEFEROXAMINE MESYLATE 207384 002 ANDA DEFEROXAMINE MESYLATE INJECTABLE;INJECTION 2GM/VIAL No No AP 2017/09/29 GLAND PHARMA LTD RX 详细信息
DEFEROXAMINE MESYLATE 207384 001 ANDA DEFEROXAMINE MESYLATE INJECTABLE;INJECTION 500MG/VIAL No No AP 2017/09/29 GLAND PHARMA LTD RX 详细信息
DEFEROXAMINE MESYLATE 076019 002 ANDA DEFEROXAMINE MESYLATE INJECTABLE;INJECTION 2GM/VIAL No Yes AP 2004/03/17 HOSPIRA RX 详细信息
DEFEROXAMINE MESYLATE 076019 001 ANDA DEFEROXAMINE MESYLATE INJECTABLE;INJECTION 500MG/VIAL No No AP 2004/03/17 HOSPIRA RX 详细信息
DEFEROXAMINE MESYLATE 078086 002 ANDA DEFEROXAMINE MESYLATE INJECTABLE;INJECTION 2GM/VIAL No No AP 2007/05/30 WEST-WARD PHARMS INT RX 详细信息
DEFEROXAMINE MESYLATE 078086 001 ANDA DEFEROXAMINE MESYLATE INJECTABLE;INJECTION 500MG/VIAL No No AP 2007/05/30 WEST-WARD PHARMS INT RX 详细信息
DELATESTRYL 009165 001 NDA TESTOSTERONE ENANTHATE INJECTABLE;INJECTION 200MG/ML No No Approved Prior to Jan 1, 1982 ENDO PHARMS DISCN 详细信息
DELATESTRYL 009165 003 NDA TESTOSTERONE ENANTHATE INJECTABLE;INJECTION 200MG/ML Yes No Approved Prior to Jan 1, 1982 ENDO PHARMS DISCN 详细信息
DELESTROGEN 009402 002 NDA ESTRADIOL VALERATE INJECTABLE;INJECTION 10MG/ML Yes Yes AO Approved Prior to Jan 1, 1982 PAR STERILE PRODUCTS RX 详细信息
DELESTROGEN 009402 004 NDA ESTRADIOL VALERATE INJECTABLE;INJECTION 20MG/ML Yes Yes AO Approved Prior to Jan 1, 1982 PAR STERILE PRODUCTS RX 详细信息
当前数据更新日期：2023年04月01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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