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
68180-479-03 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)
0615-7992-05 0615-7992 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20190418 N/A ANDA ANDA078103 NCS HealthCare of KY, LLC dba Vangard Labs SIMVASTATIN 10 mg/1 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-7992-05)
0615-7992-39 0615-7992 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20070612 N/A ANDA ANDA078103 NCS HealthCare of KY, LLC dba Vangard Labs SIMVASTATIN 10 mg/1 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-7992-39)
70518-3349-2 70518-3349 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20230221 N/A ANDA ANDA078103 REMEDYREPACK INC. SIMVASTATIN 40 mg/1 30 TABLET, FILM COATED in 1 BLISTER PACK (70518-3349-2)
70518-3349-3 70518-3349 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20230403 N/A ANDA ANDA078103 REMEDYREPACK INC. SIMVASTATIN 40 mg/1 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-3349-3)
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)
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)
72189-452-30 72189-452 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20230324 N/A ANDA ANDA078103 Direct_Rx SIMVASTATIN 10 mg/1 30 TABLET, FILM COATED in 1 BOTTLE (72189-452-30)
72189-452-90 72189-452 HUMAN PRESCRIPTION DRUG Simvastatin Simvastatin TABLET, FILM COATED ORAL 20230324 N/A ANDA ANDA078103 Direct_Rx SIMVASTATIN 10 mg/1 90 TABLET, FILM COATED in 1 BOTTLE (72189-452-90)
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)
68084-511-01 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)
50090-6306-1 50090-6306 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20221229 N/A ANDA ANDA078103 A-S Medication Solutions SIMVASTATIN 20 mg/1 30 TABLET, FILM COATED in 1 BOTTLE (50090-6306-1)
50090-6306-2 50090-6306 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20221229 N/A ANDA ANDA078103 A-S Medication Solutions SIMVASTATIN 20 mg/1 90 TABLET, FILM COATED in 1 BOTTLE (50090-6306-2)
50090-6306-3 50090-6306 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20221229 N/A ANDA ANDA078103 A-S Medication Solutions SIMVASTATIN 20 mg/1 200 TABLET, FILM COATED in 1 BOTTLE (50090-6306-3)
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)
68645-527-54 68645-527 HUMAN PRESCRIPTION DRUG SIMVASTATIN SIMVASTATIN TABLET, FILM COATED ORAL 20151202 N/A ANDA ANDA078103 Legacy Pharmaceutical Packaging, LLC SIMVASTATIN 40 mg/1 30 TABLET, FILM COATED in 1 BOTTLE (68645-527-54)
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