美国药品NDC(国家药品编码)与药品说明书数据库(U.S. FDA National Drug Code DataBase)
检索条件:" 注册申请号=NDA212909"
NDC包装代码 产品NDC 产品类型 商品名 通用名 剂型 给药途径 上市日期 结束日期 市场类别 申请号 标签持有者 活性成分 规格 包装描述
43598-199-10 43598-199 HUMAN PRESCRIPTION DRUG Biorphen Phenylephrine hydrochloride INJECTION, SOLUTION INTRAVENOUS 20221125 N/A NDA NDA212909 Dr. Reddy's Laboratories Inc. PHENYLEPHRINE HYDROCHLORIDE 10 mg/mL 10 AMPULE in 1 CARTON (43598-199-10) / 1 mL in 1 AMPULE (43598-199-01)
71863-202-06 71863-202 HUMAN PRESCRIPTION DRUG Biorphen Phenylephrine hydrochloride INJECTION, SOLUTION INTRAVENOUS 20191115 N/A NDA NDA212909 Eton Pharmaceuticals, Inc. PHENYLEPHRINE HYDROCHLORIDE .1 mg/mL 10 AMPULE in 1 CARTON (71863-202-06) / 5 mL in 1 AMPULE (71863-202-05)
71863-208-05 71863-208 HUMAN PRESCRIPTION DRUG Biorphen Phenylephrine hydrochloride INJECTION, SOLUTION INTRAVENOUS 20220325 N/A NDA NDA212909 Eton Pharmaceuticals, Inc. PHENYLEPHRINE HYDROCHLORIDE .1 mg/mL 1 VIAL in 1 CARTON (71863-208-05) / 5 mL in 1 VIAL
43598-172-15 43598-172 HUMAN PRESCRIPTION DRUG Biorphen Phenylephrine hydrochloride INJECTION, SOLUTION INTRAVENOUS 20221125 N/A NDA NDA212909 Dr. Reddy's Laboratories Inc. PHENYLEPHRINE HYDROCHLORIDE .1 mg/mL 10 AMPULE in 1 CARTON (43598-172-15) / 5 mL in 1 AMPULE (43598-172-05)
43598-172-25 43598-172 HUMAN PRESCRIPTION DRUG Biorphen Phenylephrine hydrochloride INJECTION, SOLUTION INTRAVENOUS 20240510 N/A NDA NDA212909 Dr. Reddy's Laboratories Inc. PHENYLEPHRINE HYDROCHLORIDE .1 mg/mL 5 mL in 1 VIAL (43598-172-25)
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