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
50090-5788-1 50090-5788 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20211008 N/A ANDA ANDA078103 A-S Medication Solutions SIMVASTATIN 80 mg/1 90 TABLET, FILM COATED in 1 BOTTLE (50090-5788-1)
72789-304-30 72789-304 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20230410 N/A ANDA ANDA078103 PD-Rx Pharmaceuticals, Inc. SIMVASTATIN 40 mg/1 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-304-30)
72789-304-90 72789-304 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20220301 N/A ANDA ANDA078103 PD-Rx Pharmaceuticals, Inc. SIMVASTATIN 40 mg/1 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-304-90)
72789-316-30 72789-316 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20230410 N/A ANDA ANDA078103 PD-Rx Pharmaceuticals, Inc. SIMVASTATIN 20 mg/1 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-316-30)
72789-316-90 72789-316 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20230323 N/A ANDA ANDA078103 PD-Rx Pharmaceuticals, Inc. SIMVASTATIN 20 mg/1 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-316-90)
72789-320-30 72789-320 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20230418 N/A ANDA ANDA078103 PD-Rx Pharmaceuticals, Inc. SIMVASTATIN 10 mg/1 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-320-30)
42708-168-30 42708-168 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20230320 N/A ANDA ANDA078103 QPharma Inc SIMVASTATIN 40 mg/1 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42708-168-30)
71335-9717-1 71335-9717 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20230404 N/A ANDA ANDA078103 Bryant Ranch Prepack SIMVASTATIN 80 mg/1 30 TABLET, FILM COATED in 1 BOTTLE (71335-9717-1)
71335-9717-2 71335-9717 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20240405 N/A ANDA ANDA078103 Bryant Ranch Prepack SIMVASTATIN 80 mg/1 60 TABLET, FILM COATED in 1 BOTTLE (71335-9717-2)
71335-9717-3 71335-9717 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20230821 N/A ANDA ANDA078103 Bryant Ranch Prepack SIMVASTATIN 80 mg/1 90 TABLET, FILM COATED in 1 BOTTLE (71335-9717-3)
71335-9717-4 71335-9717 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20240405 N/A ANDA ANDA078103 Bryant Ranch Prepack SIMVASTATIN 80 mg/1 100 TABLET, FILM COATED in 1 BOTTLE (71335-9717-4)
71335-9717-5 71335-9717 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20240405 N/A ANDA ANDA078103 Bryant Ranch Prepack SIMVASTATIN 80 mg/1 10 TABLET, FILM COATED in 1 BOTTLE (71335-9717-5)
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)
53002-2527-3 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)
53002-2527-9 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)
53002-2528-3 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)
53002-2528-9 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)
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)
50090-6236-0 50090-6236 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20221121 N/A ANDA ANDA078103 A-S Medication Solutions SIMVASTATIN 10 mg/1 90 TABLET, FILM COATED in 1 BOTTLE (50090-6236-0)
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