千赢国际

美国FDA亚洲城橙皮书亚洲城
(U.S. FDA Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations)
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 是否参比亚洲城 是否生物等效参考标准 手机版等效代码 产品ca88日期 申请人 市场状态 登陆及市场独占权
APOGEN 062289 002 ANDA GENTAMICIN SULFATE INJECTABLE;INJECTION EQ 40MG BASE/ML No No Approved Prior to Jan 1, 1982 KING PHARMS DISCN 详细信息
APRESOLINE 008303 003 NDA HYDRALAZINE HYDROCHLORIDE INJECTABLE;INJECTION 20MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No Approved Prior to Jan 1, 1982 NOVARTIS DISCN 详细信息
AQUAMEPHYTON 012223 002 NDA PHYTONADIONE INJECTABLE;INJECTION 1MG/0.5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No Approved Prior to Jan 1, 1982 TELIGENT DISCN 详细信息
AQUAMEPHYTON 012223 001 NDA PHYTONADIONE INJECTABLE;INJECTION 10MG/ML ***Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No Approved Prior to Jan 1, 1982 TELIGENT DISCN 详细信息
AQUASOL A 006823 001 NDA VITAMIN A PALMITATE INJECTABLE;INJECTION EQ 50,000 UNITS BASE/ML Yes Yes Approved Prior to Jan 1, 1982 CASPER PHARMA LLC RX 详细信息
ARALEN HYDROCHLORIDE 006002 002 NDA CHLOROQUINE HYDROCHLORIDE INJECTABLE;INJECTION EQ 40MG BASE/ML No No Approved Prior to Jan 1, 1982 SANOFI AVENTIS US DISCN 详细信息
ARAMINE 009509 002 NDA METARAMINOL BITARTRATE INJECTABLE;INJECTION EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 1987/12/22 MERCK DISCN 详细信息
ARDUAN 019638 001 NDA PIPECURONIUM BROMIDE INJECTABLE;INJECTION 10MG/VIAL No No 1990/06/26 ORGANON USA INC DISCN 详细信息
AREDIA 020036 001 NDA PAMIDRONATE DISODIUM INJECTABLE;INJECTION 30MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 1991/10/31 NOVARTIS DISCN 详细信息
AREDIA 020036 003 NDA PAMIDRONATE DISODIUM INJECTABLE;INJECTION 60MG/VIAL No No 1993/05/06 NOVARTIS DISCN 详细信息
AREDIA 020036 004 NDA PAMIDRONATE DISODIUM INJECTABLE;INJECTION 90MG/VIAL No No 1993/05/06 NOVARTIS DISCN 详细信息
ARESTOCAINE HYDROCHLORIDE 084777 002 ANDA MEPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 3% No No 1982/04/18 SOLVAY DISCN 详细信息
ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN 085010 001 ANDA LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE INJECTABLE;INJECTION 0.05MG/ML;2% No No Approved Prior to Jan 1, 1982 SOLVAY DISCN 详细信息
ARFONAD 008983 001 NDA TRIMETHAPHAN CAMSYLATE INJECTABLE;INJECTION 50MG/ML No No Approved Prior to Jan 1, 1982 ROCHE DISCN 详细信息
ARGATROBAN 206698 001 ANDA ARGATROBAN INJECTABLE;INJECTION 250MG/2.5ML (100MG/ML) No No AP 2018/01/26 AMNEAL PHARMS CO RX 详细信息
ARGATROBAN 201811 001 NDA ARGATROBAN INJECTABLE;INJECTION 250MG/2.5ML (100MG/ML) No No AP 2015/03/23 FRESENIUS KABI USA RX 详细信息
ARGATROBAN 203049 002 NDA ARGATROBAN INJECTABLE;INJECTION 50MG/50ML (1MG/ML) Yes Yes 2016/09/30 HIKMA PHARM CO LTD RX 详细信息
ARGATROBAN 203049 001 NDA ARGATROBAN INJECTABLE;INJECTION 250MG/2.5ML (100MG/ML) Yes Yes AP 2012/01/05 HIKMA PHARM CO LTD RX 详细信息
ARGATROBAN 204120 001 ANDA ARGATROBAN INJECTABLE;INJECTION 250MG/2.5ML (100MG/ML) No No AP 2016/09/21 HOSPIRA INC RX 详细信息
ARGATROBAN 202626 001 ANDA ARGATROBAN INJECTABLE;INJECTION 250MG/2.5ML (100MG/ML) No No AP 2014/06/30 MYLAN INSTITUTIONAL RX 详细信息
当前数据更新日期:2020年07月04日,更多信息请点击此处查询美国FDA亚洲城亚洲城
亚洲城说明:本数据与美国FDA官方亚洲城橙皮书亚洲城同步,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,并且可以回溯登陆及市场独占权(市场排他数据)历史信息。
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