美国FDA药品数据库(U.S. FDA Drugs Database)
检索条件:" 药品名称=NARCAN"
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 RLD RS 申请号原始批准/暂定批准日期 产品号批准日期 申请人 市场状态
NARCAN 016636 001 NDA NALOXONE HYDROCHLORIDE INJECTABLE;INJECTION 0.4MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1971/04/13 Approved Prior to Jan 1, 1982 ADAPT Discontinued
NARCAN 016636 002 NDA NALOXONE HYDROCHLORIDE INJECTABLE;INJECTION 0.02MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1971/04/13 Approved Prior to Jan 1, 1982 ADAPT Discontinued
NARCAN 016636 003 NDA NALOXONE HYDROCHLORIDE INJECTABLE;INJECTION 1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 1971/04/13 1982/06/14 ADAPT Discontinued
NARCAN 071083 001 ANDA NALOXONE HYDROCHLORIDE INJECTABLE;INJECTION 0.4MG/ML No No 1988/07/28 1988/07/28 BRISTOL MYERS SQUIBB Discontinued
NARCAN 071084 001 ANDA NALOXONE HYDROCHLORIDE INJECTABLE;INJECTION 1MG/ML No No 1988/07/28 1988/07/28 BRISTOL MYERS SQUIBB Discontinued
NARCAN 071311 001 ANDA NALOXONE HYDROCHLORIDE INJECTABLE;INJECTION 1MG/ML No No 1988/07/28 1988/07/28 BRISTOL MYERS SQUIBB Discontinued
NARCAN 208411 001 NDA NALOXONE HYDROCHLORIDE SPRAY, METERED;NASAL 4MG/SPRAY Yes Yes 2015/11/18 2015/11/18 EMERGENT Over-the-counter
NARCAN 208411 002 NDA NALOXONE HYDROCHLORIDE SPRAY, METERED;NASAL 2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Yes No 2015/11/18 2017/01/24 EMERGENT Discontinued
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