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=ANDA040649"
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
70436-155-41 70436-155 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution SOLUTION ORAL 20201005 N/A ANDA ANDA040649 Slate Run Pharmaceuticals, LLC DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15 mg/5mL; 6.25 mg/5mL 118 mL in 1 BOTTLE (70436-155-41)
70436-155-42 70436-155 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution SOLUTION ORAL 20201005 N/A ANDA ANDA040649 Slate Run Pharmaceuticals, LLC DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15 mg/5mL; 6.25 mg/5mL 473 mL in 1 BOTTLE (70436-155-42)
0121-1070-04 0121-1070 HUMAN PRESCRIPTION DRUG Promethazine DM Promethazine Hydrochloride and Dextromethorphan Hydrobromide SOLUTION ORAL 20250604 N/A ANDA ANDA040649 PAI Holdings, LLC dba PAI Pharma DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15 mg/5mL; 6.25 mg/5mL 118 mL in 1 BOTTLE (0121-1070-04)
0121-1070-16 0121-1070 HUMAN PRESCRIPTION DRUG Promethazine DM Promethazine Hydrochloride and Dextromethorphan Hydrobromide SOLUTION ORAL 20250604 N/A ANDA ANDA040649 PAI Holdings, LLC dba PAI Pharma DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15 mg/5mL; 6.25 mg/5mL 473 mL in 1 BOTTLE (0121-1070-16)
68071-3551-4 68071-3551 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution SOLUTION ORAL 20231201 N/A ANDA ANDA040649 NuCare Pharmaceuticals,Inc. DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15 mg/5mL; 6.25 mg/5mL 118 mL in 1 BOTTLE (68071-3551-4)
50090-6585-0 50090-6585 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral SOLUTION ORAL 20230809 N/A ANDA ANDA040649 A-S Medication Solutions DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15 mg/5mL; 6.25 mg/5mL 118 mL in 1 BOTTLE (50090-6585-0)
71205-654-04 71205-654 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution SOLUTION ORAL 20220426 N/A ANDA ANDA040649 Proficient Rx LP DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15 mg/5mL; 6.25 mg/5mL 118 mL in 1 BOTTLE (71205-654-04)
17856-0155-1 17856-0155 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution SOLUTION ORAL 20230913 N/A ANDA ANDA040649 ATLANTIC BIOLOGICALS CORP. DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15 mg/5mL; 6.25 mg/5mL 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0155-1) / 5 mL in 1 CUP, UNIT-DOSE
68788-8100-1 68788-8100 HUMAN PRESCRIPTION DRUG Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution SOLUTION ORAL 20211008 N/A ANDA ANDA040649 Preferred Pharmaceuticals Inc. DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE 15 mg/5mL; 6.25 mg/5mL 118 mL in 1 BOTTLE (68788-8100-1)
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