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
68180-465-09 68180-465 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20160219 N/A ANDA ANDA078103 Lupin Pharmaceuticals, Inc. SIMVASTATIN 80 mg/1 90 TABLET, FILM COATED in 1 BOTTLE (68180-465-09)
68180-478-01 68180-478 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20070612 N/A ANDA ANDA078103 Lupin Pharmaceuticals, Inc. SIMVASTATIN 10 mg/1 30 TABLET, FILM COATED in 1 BOTTLE (68180-478-01)
68180-478-02 68180-478 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20070612 N/A ANDA ANDA078103 Lupin Pharmaceuticals, Inc. SIMVASTATIN 10 mg/1 90 TABLET, FILM COATED in 1 BOTTLE (68180-478-02)
68180-478-03 68180-478 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20070612 N/A ANDA ANDA078103 Lupin Pharmaceuticals, Inc. SIMVASTATIN 10 mg/1 1000 TABLET, FILM COATED in 1 BOTTLE (68180-478-03)
68180-479-01 68180-479 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20070614 N/A ANDA ANDA078103 Lupin Pharmaceuticals, Inc. SIMVASTATIN 20 mg/1 30 TABLET, FILM COATED in 1 BOTTLE (68180-479-01)
68180-479-02 68180-479 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20070614 N/A ANDA ANDA078103 Lupin Pharmaceuticals, Inc. SIMVASTATIN 20 mg/1 90 TABLET, FILM COATED in 1 BOTTLE (68180-479-02)
68180-479-03 68180-479 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20070614 N/A ANDA ANDA078103 Lupin Pharmaceuticals, Inc. SIMVASTATIN 20 mg/1 1000 TABLET, FILM COATED in 1 BOTTLE (68180-479-03)
71610-966-30 71610-966 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20251201 N/A ANDA ANDA078103 Aphena Pharma Solutions - Tennessee, LLC SIMVASTATIN 10 mg/1 30 TABLET, FILM COATED in 1 BOTTLE (71610-966-30)
71610-966-45 71610-966 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20251201 N/A ANDA ANDA078103 Aphena Pharma Solutions - Tennessee, LLC SIMVASTATIN 10 mg/1 45 TABLET, FILM COATED in 1 BOTTLE (71610-966-45)
71610-966-53 71610-966 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20251201 N/A ANDA ANDA078103 Aphena Pharma Solutions - Tennessee, LLC SIMVASTATIN 10 mg/1 60 TABLET, FILM COATED in 1 BOTTLE (71610-966-53)
71610-966-60 71610-966 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20251201 N/A ANDA ANDA078103 Aphena Pharma Solutions - Tennessee, LLC SIMVASTATIN 10 mg/1 90 TABLET, FILM COATED in 1 BOTTLE (71610-966-60)
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)
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)
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)
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)
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