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=ANDA209603"
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
70377-062-12 70377-062 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20210527 N/A ANDA ANDA209603 Biocon Pharma Inc. LABETALOL HYDROCHLORIDE 300 mg/1 100 TABLET, FILM COATED in 1 BOTTLE (70377-062-12)
70377-063-13 70377-063 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20241202 N/A ANDA ANDA209603 Biocon Pharma Inc. LABETALOL HYDROCHLORIDE 400 mg/1 500 TABLET, FILM COATED in 1 BOTTLE (70377-063-13)
70377-062-13 70377-062 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20210527 N/A ANDA ANDA209603 Biocon Pharma Inc. LABETALOL HYDROCHLORIDE 300 mg/1 500 TABLET, FILM COATED in 1 BOTTLE (70377-062-13)
70377-063-11 70377-063 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20250807 N/A ANDA ANDA209603 Biocon Pharma Inc. LABETALOL HYDROCHLORIDE 400 mg/1 30 TABLET, FILM COATED in 1 BOTTLE (70377-063-11)
70377-063-12 70377-063 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20241202 N/A ANDA ANDA209603 Biocon Pharma Inc. LABETALOL HYDROCHLORIDE 400 mg/1 100 TABLET, FILM COATED in 1 BOTTLE (70377-063-12)
60760-991-90 60760-991 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20250312 N/A ANDA ANDA209603 ST. MARY'S MEDICAL PARK PHARMACY LABETALOL HYDROCHLORIDE 100 mg/1 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-991-90)
68071-3878-9 68071-3878 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20250728 N/A ANDA ANDA209603 NuCare Pharmaceuticals , Inc. LABETALOL HYDROCHLORIDE 200 mg/1 90 TABLET, FILM COATED in 1 BOTTLE (68071-3878-9)
0615-8512-39 0615-8512 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20240614 N/A ANDA ANDA209603 NCS HealthCare of KY, LLC dba Vangard Labs LABETALOL HYDROCHLORIDE 100 mg/1 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8512-39)
0615-8513-39 0615-8513 HUMAN PRESCRIPTION DRUG Labetalol Hydrochloride Labetalol Hydrochloride TABLET, FILM COATED ORAL 20240618 N/A ANDA ANDA209603 NCS HealthCare of KY, LLC dba Vangard Labs LABETALOL HYDROCHLORIDE 200 mg/1 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8513-39)
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