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=ANDA078103"
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
51655-387-26 51655-387 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20230328 N/A ANDA ANDA078103 Northwind Pharmaceuticals, LLC SIMVASTATIN 40 mg/1 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-387-26)
51655-459-26 51655-459 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20230417 N/A ANDA ANDA078103 Northwind Pharmaceuticals, LLC SIMVASTATIN 20 mg/1 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-459-26)
51655-459-52 51655-459 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20230329 N/A ANDA ANDA078103 Northwind Pharmaceuticals, LLC SIMVASTATIN 20 mg/1 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-459-52)
53002-2527-0 53002-2527 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20230101 N/A ANDA ANDA078103 RPK Pharmaceuticals, Inc. SIMVASTATIN 10 mg/1 100 TABLET, FILM COATED in 1 BOTTLE (53002-2527-0)
53002-2528-3 53002-2528 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20230101 N/A ANDA ANDA078103 RPK Pharmaceuticals, Inc. SIMVASTATIN 20 mg/1 30 TABLET, FILM COATED in 1 BOTTLE (53002-2528-3)
53002-2527-9 53002-2527 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20230101 N/A ANDA ANDA078103 RPK Pharmaceuticals, Inc. SIMVASTATIN 10 mg/1 90 TABLET, FILM COATED in 1 BOTTLE (53002-2527-9)
53002-2528-0 53002-2528 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20230101 N/A ANDA ANDA078103 RPK Pharmaceuticals, Inc. SIMVASTATIN 20 mg/1 100 TABLET, FILM COATED in 1 BOTTLE (53002-2528-0)
53002-2527-3 53002-2527 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20230101 N/A ANDA ANDA078103 RPK Pharmaceuticals, Inc. SIMVASTATIN 10 mg/1 30 TABLET, FILM COATED in 1 BOTTLE (53002-2527-3)
53002-2528-9 53002-2528 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20230101 N/A ANDA ANDA078103 RPK Pharmaceuticals, Inc. SIMVASTATIN 20 mg/1 90 TABLET, FILM COATED in 1 BOTTLE (53002-2528-9)
53002-2569-0 53002-2569 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20230101 N/A ANDA ANDA078103 RPK Pharmaceuticals, Inc. SIMVASTATIN 40 mg/1 100 TABLET, FILM COATED in 1 BOTTLE (53002-2569-0)
53002-2569-3 53002-2569 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20230101 N/A ANDA ANDA078103 RPK Pharmaceuticals, Inc. SIMVASTATIN 40 mg/1 30 TABLET, FILM COATED in 1 BOTTLE (53002-2569-3)
53002-2569-9 53002-2569 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20230101 N/A ANDA ANDA078103 RPK Pharmaceuticals, Inc. SIMVASTATIN 40 mg/1 90 TABLET, FILM COATED in 1 BOTTLE (53002-2569-9)
60687-210-01 60687-210 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20160608 N/A ANDA ANDA078103 American Health Packaging SIMVASTATIN 40 mg/1 100 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-210-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (60687-210-11)
61919-764-90 61919-764 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20210118 N/A ANDA ANDA078103 DIRECT RX SIMVASTATIN 80 mg/1 90 TABLET, FILM COATED in 1 BOTTLE (61919-764-90)
68071-4331-9 68071-4331 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20180312 N/A ANDA ANDA078103 NuCare Pharmaceuticals,Inc. SIMVASTATIN 10 mg/1 90 TABLET, FILM COATED in 1 BOTTLE (68071-4331-9)
68084-512-01 68084-512 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20110908 N/A ANDA ANDA078103 American Health Packaging SIMVASTATIN 20 mg/1 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-512-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-512-11)
68084-511-01 68084-511 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20110819 N/A ANDA ANDA078103 American Health Packaging SIMVASTATIN 10 mg/1 100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-511-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-511-11)
68788-8342-6 68788-8342 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20230203 N/A ANDA ANDA078103 Preferred Pharmaceuticals, Inc. SIMVASTATIN 20 mg/1 60 TABLET, FILM COATED in 1 BOTTLE (68788-8342-6)
68788-8342-1 68788-8342 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20230203 N/A ANDA ANDA078103 Preferred Pharmaceuticals, Inc. SIMVASTATIN 20 mg/1 100 TABLET, FILM COATED in 1 BOTTLE (68788-8342-1)
68788-8342-3 68788-8342 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20230203 N/A ANDA ANDA078103 Preferred Pharmaceuticals, Inc. SIMVASTATIN 20 mg/1 30 TABLET, FILM COATED in 1 BOTTLE (68788-8342-3)
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