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=ANDA203653"
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
35573-445-25 35573-445 HUMAN PRESCRIPTION DRUG Levalbuterol Levalbuterol Hydrochloride SOLUTION RESPIRATORY (INHALATION) 20210401 N/A ANDA ANDA203653 Burel Pharmaceuticals, LLC LEVALBUTEROL HYDROCHLORIDE 1.25 mg/3mL 25 POUCH in 1 CARTON (35573-445-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE
35573-444-25 35573-444 HUMAN PRESCRIPTION DRUG Levalbuterol Levalbuterol Hydrochloride SOLUTION RESPIRATORY (INHALATION) 20210401 N/A ANDA ANDA203653 Burel Pharmaceuticals, LLC LEVALBUTEROL HYDROCHLORIDE .63 mg/3mL 25 POUCH in 1 CARTON (35573-444-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE
35573-443-25 35573-443 HUMAN PRESCRIPTION DRUG Levalbuterol Levalbuterol Hydrochloride SOLUTION RESPIRATORY (INHALATION) 20210401 N/A ANDA ANDA203653 Burel Pharmaceuticals, LLC LEVALBUTEROL HYDROCHLORIDE .31 mg/3mL 25 POUCH in 1 CARTON (35573-443-25) / 25 VIAL, SINGLE-DOSE in 1 POUCH / 3 mL in 1 VIAL, SINGLE-DOSE
72162-2083-2 72162-2083 HUMAN PRESCRIPTION DRUG Levalbuterol Levalbuterol Hydrochloride SOLUTION RESPIRATORY (INHALATION) 20230914 N/A ANDA ANDA203653 Bryant Ranch Prepack LEVALBUTEROL HYDROCHLORIDE 1.25 mg/3mL 1 POUCH in 1 CARTON (72162-2083-2) / 25 AMPULE in 1 POUCH / 3 mL in 1 AMPULE
72162-2081-2 72162-2081 HUMAN PRESCRIPTION DRUG Levalbuterol Levalbuterol Hydrochloride SOLUTION RESPIRATORY (INHALATION) 20230913 N/A ANDA ANDA203653 Bryant Ranch Prepack LEVALBUTEROL HYDROCHLORIDE .31 mg/3mL 1 POUCH in 1 CARTON (72162-2081-2) / 25 AMPULE in 1 POUCH / 3 mL in 1 AMPULE
72162-2082-2 72162-2082 HUMAN PRESCRIPTION DRUG Levalbuterol Levalbuterol Hydrochloride SOLUTION RESPIRATORY (INHALATION) 20230914 N/A ANDA ANDA203653 Bryant Ranch Prepack LEVALBUTEROL HYDROCHLORIDE .63 mg/3mL 1 POUCH in 1 CARTON (72162-2082-2) / 25 AMPULE in 1 POUCH / 3 mL in 1 AMPULE
50090-6377-0 50090-6377 HUMAN PRESCRIPTION DRUG Levalbuterol Levalbuterol Hydrochloride SOLUTION RESPIRATORY (INHALATION) 20230220 N/A ANDA ANDA203653 A-S Medication Solutions LEVALBUTEROL HYDROCHLORIDE .63 mg/3mL 1 POUCH in 1 CARTON (50090-6377-0) / 25 mL in 1 POUCH
76204-700-25 76204-700 HUMAN PRESCRIPTION DRUG Levalbuterol Levalbuterol Hydrochloride SOLUTION RESPIRATORY (INHALATION) 20170217 N/A ANDA ANDA203653 Ritedose Pharmaceuticals, LLC LEVALBUTEROL HYDROCHLORIDE .31 mg/3mL 1 POUCH in 1 CARTON (76204-700-25) / 25 AMPULE in 1 POUCH (76204-700-15) / 3 mL in 1 AMPULE
76204-800-25 76204-800 HUMAN PRESCRIPTION DRUG Levalbuterol Levalbuterol Hydrochloride SOLUTION RESPIRATORY (INHALATION) 20170217 N/A ANDA ANDA203653 Ritedose Pharmaceuticals, LLC LEVALBUTEROL HYDROCHLORIDE .63 mg/3mL 1 POUCH in 1 CARTON (76204-800-25) / 25 AMPULE in 1 POUCH (76204-800-15) / 3 mL in 1 AMPULE
76204-800-55 76204-800 HUMAN PRESCRIPTION DRUG Levalbuterol Levalbuterol Hydrochloride SOLUTION RESPIRATORY (INHALATION) 20170217 N/A ANDA ANDA203653 Ritedose Pharmaceuticals, LLC LEVALBUTEROL HYDROCHLORIDE .63 mg/3mL 5 POUCH in 1 CARTON (76204-800-55) / 5 AMPULE in 1 POUCH (76204-800-05) / 3 mL in 1 AMPULE
76204-900-01 76204-900 HUMAN PRESCRIPTION DRUG Levalbuterol Levalbuterol Hydrochloride SOLUTION RESPIRATORY (INHALATION) 20170217 N/A ANDA ANDA203653 Ritedose Pharmaceuticals, LLC LEVALBUTEROL HYDROCHLORIDE 1.25 mg/3mL 30 POUCH in 1 CARTON (76204-900-01) / 1 AMPULE in 1 POUCH (76204-900-11) / 3 mL in 1 AMPULE
76204-900-25 76204-900 HUMAN PRESCRIPTION DRUG Levalbuterol Levalbuterol Hydrochloride SOLUTION RESPIRATORY (INHALATION) 20170217 N/A ANDA ANDA203653 Ritedose Pharmaceuticals, LLC LEVALBUTEROL HYDROCHLORIDE 1.25 mg/3mL 1 POUCH in 1 CARTON (76204-900-25) / 25 AMPULE in 1 POUCH (76204-900-15) / 3 mL in 1 AMPULE
76204-700-55 76204-700 HUMAN PRESCRIPTION DRUG Levalbuterol Levalbuterol Hydrochloride SOLUTION RESPIRATORY (INHALATION) 20170217 N/A ANDA ANDA203653 Ritedose Pharmaceuticals, LLC LEVALBUTEROL HYDROCHLORIDE .31 mg/3mL 5 POUCH in 1 CARTON (76204-700-55) / 5 AMPULE in 1 POUCH (76204-700-05) / 3 mL in 1 AMPULE
76204-800-01 76204-800 HUMAN PRESCRIPTION DRUG Levalbuterol Levalbuterol Hydrochloride SOLUTION RESPIRATORY (INHALATION) 20170217 N/A ANDA ANDA203653 Ritedose Pharmaceuticals, LLC LEVALBUTEROL HYDROCHLORIDE .63 mg/3mL 30 POUCH in 1 CARTON (76204-800-01) / 1 AMPULE in 1 POUCH (76204-800-11) / 3 mL in 1 AMPULE
76204-700-01 76204-700 HUMAN PRESCRIPTION DRUG Levalbuterol Levalbuterol Hydrochloride SOLUTION RESPIRATORY (INHALATION) 20170217 N/A ANDA ANDA203653 Ritedose Pharmaceuticals, LLC LEVALBUTEROL HYDROCHLORIDE .31 mg/3mL 30 POUCH in 1 CARTON (76204-700-01) / 1 AMPULE in 1 POUCH (76204-700-11) / 3 mL in 1 AMPULE
76204-900-55 76204-900 HUMAN PRESCRIPTION DRUG Levalbuterol Levalbuterol Hydrochloride SOLUTION RESPIRATORY (INHALATION) 20170217 N/A ANDA ANDA203653 Ritedose Pharmaceuticals, LLC LEVALBUTEROL HYDROCHLORIDE 1.25 mg/3mL 5 POUCH in 1 CARTON (76204-900-55) / 5 AMPULE in 1 POUCH (76204-900-05) / 3 mL in 1 AMPULE
0115-9930-78 0115-9930 HUMAN PRESCRIPTION DRUG Levalbuterol Levalbuterol Hydrochloride SOLUTION RESPIRATORY (INHALATION) 20170217 N/A ANDA ANDA203653 Amneal Pharmaceuticals of New York LLC LEVALBUTEROL HYDROCHLORIDE .31 mg/3mL 1 POUCH in 1 CARTON (0115-9930-78) / 25 AMPULE in 1 POUCH (0115-9930-76) / 3 mL in 1 AMPULE
0115-9931-78 0115-9931 HUMAN PRESCRIPTION DRUG Levalbuterol Levalbuterol Hydrochloride SOLUTION RESPIRATORY (INHALATION) 20170217 N/A ANDA ANDA203653 Amneal Pharmaceuticals of New York LLC LEVALBUTEROL HYDROCHLORIDE .63 mg/3mL 1 POUCH in 1 CARTON (0115-9931-78) / 25 AMPULE in 1 POUCH (0115-9931-76) / 3 mL in 1 AMPULE
0378-9692-52 0378-9692 HUMAN PRESCRIPTION DRUG Levalbuterol Levalbuterol SOLUTION RESPIRATORY (INHALATION) 20180910 N/A ANDA ANDA203653 Mylan Pharmaceuticals Inc. LEVALBUTEROL HYDROCHLORIDE 1.25 mg/3mL 1 POUCH in 1 CARTON (0378-9692-52) / 25 AMPULE in 1 POUCH (0378-9692-62) / 3 mL in 1 AMPULE
0115-9932-78 0115-9932 HUMAN PRESCRIPTION DRUG Levalbuterol Levalbuterol Hydrochloride SOLUTION RESPIRATORY (INHALATION) 20170217 N/A ANDA ANDA203653 Amneal Pharmaceuticals of New York LLC LEVALBUTEROL HYDROCHLORIDE 1.25 mg/3mL 1 POUCH in 1 CARTON (0115-9932-78) / 25 AMPULE in 1 POUCH (0115-9932-76) / 3 mL in 1 AMPULE
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