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 44820 条，共 2241 页，当前第 100 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
STAVUDINE 077774 001 ANDA STAVUDINE FOR SOLUTION;ORAL 1MG/ML No No 2008/12/29 AUROBINDO PHARMA DISCN 详细信息
STAVUDINE 078030 001 ANDA STAVUDINE FOR SOLUTION;ORAL 1MG/ML No No 2009/03/20 CIPLA LTD DISCN 详细信息
SUFLAVE 215344 001 NDA MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM SULFATE FOR SOLUTION;ORAL 0.9GM/BOT;178.7GM/BOT;1.12GM/BOT;0.5GM/BOT;7.3GM/BOT Yes Yes 2023/06/15 BRAINTREE LABS RX 详细信息
TEGOPEN 061453 001 ANDA CLOXACILLIN SODIUM FOR SOLUTION;ORAL EQ 125MG BASE/5ML No No Approved Prior to Jan 1, 1982 APOTHECON DISCN 详细信息
TEGOPEN 050192 001 NDA CLOXACILLIN SODIUM FOR SOLUTION;ORAL EQ 125MG BASE/5ML No No Approved Prior to Jan 1, 1982 APOTHECON DISCN 详细信息
TRILYTE 076491 001 ANDA POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE FOR SOLUTION;ORAL 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT No No 2004/02/05 AUROBINDO PHARMA USA DISCN 详细信息
UNIPEN 050199 001 NDA NAFCILLIN SODIUM FOR SOLUTION;ORAL EQ 250MG BASE/5ML No No Approved Prior to Jan 1, 1982 WYETH AYERST DISCN 详细信息
V-CILLIN K 060004 001 ANDA PENICILLIN V POTASSIUM FOR SOLUTION;ORAL EQ 125MG BASE/5ML No No Approved Prior to Jan 1, 1982 LILLY DISCN 详细信息
V-CILLIN K 060004 002 ANDA PENICILLIN V POTASSIUM FOR SOLUTION;ORAL EQ 250MG BASE/5ML No No Approved Prior to Jan 1, 1982 LILLY DISCN 详细信息
VALCYTE 022257 001 NDA VALGANCICLOVIR HYDROCHLORIDE FOR SOLUTION;ORAL 50MG/ML Yes Yes AB 2009/08/28 CHEPLAPHARM RX 详细信息
VALGANCICLOVIR HYDROCHLORIDE 205220 001 ANDA VALGANCICLOVIR HYDROCHLORIDE FOR SOLUTION;ORAL 50MG/ML No No AB 2016/07/18 ACTAVIS LABS FL INC RX 详细信息
VALGANCICLOVIR HYDROCHLORIDE 212890 001 ANDA VALGANCICLOVIR HYDROCHLORIDE FOR SOLUTION;ORAL 50MG/ML No No AB 2020/01/13 AJANTA PHARMA LTD RX 详细信息
VALGANCICLOVIR HYDROCHLORIDE 216317 001 ANDA VALGANCICLOVIR HYDROCHLORIDE FOR SOLUTION;ORAL 50MG/ML No No AB 2023/04/11 APPCO RX 详细信息
VALGANCICLOVIR HYDROCHLORIDE 215124 001 ANDA VALGANCICLOVIR HYDROCHLORIDE FOR SOLUTION;ORAL 50MG/ML No No AB 2022/11/17 AUROBINDO PHARMA RX 详细信息
VALGANCICLOVIR HYDROCHLORIDE 213306 001 ANDA VALGANCICLOVIR HYDROCHLORIDE FOR SOLUTION;ORAL 50MG/ML No No AB 2020/01/31 GRANULES RX 详细信息
VALGANCICLOVIR HYDROCHLORIDE 211475 001 ANDA VALGANCICLOVIR HYDROCHLORIDE FOR SOLUTION;ORAL 50MG/ML No No AB 2022/10/04 HETERO LABS LTD V RX 详细信息
VALGANCICLOVIR HYDROCHLORIDE 210169 001 ANDA VALGANCICLOVIR HYDROCHLORIDE FOR SOLUTION;ORAL 50MG/ML No No AB 2022/02/17 MSN RX 详细信息
VANCOCIN HYDROCHLORIDE 061667 002 ANDA VANCOMYCIN HYDROCHLORIDE FOR SOLUTION;ORAL EQ 250MG BASE/5ML No Yes AA 1983/07/13 ANI PHARMS RX 详细信息
VANCOCIN HYDROCHLORIDE 061667 001 ANDA VANCOMYCIN HYDROCHLORIDE FOR SOLUTION;ORAL EQ 500MG BASE/6ML No No Approved Prior to Jan 1, 1982 ANI PHARMS DISCN 详细信息
VANCOLED 063321 002 ANDA VANCOMYCIN HYDROCHLORIDE FOR SOLUTION;ORAL EQ 250MG BASE/5ML No No 1993/10/15 LEDERLE DISCN 详细信息
当前数据更新日期：2024年04月14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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