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=ANDA075522"
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
67046-1632-3 67046-1632 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20251224 N/A ANDA ANDA075522 Coupler LLC ISOSORBIDE MONONITRATE 60 mg/1 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (67046-1632-3)
71335-2532-4 71335-2532 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20241126 N/A ANDA ANDA075522 Bryant Ranch Prepack ISOSORBIDE MONONITRATE 60 mg/1 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2532-4)
71335-2532-5 71335-2532 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20241126 N/A ANDA ANDA075522 Bryant Ranch Prepack ISOSORBIDE MONONITRATE 60 mg/1 10 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2532-5)
68071-3081-3 68071-3081 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20170314 N/A ANDA ANDA075522 NuCare Pharmaceuticals, Inc. ISOSORBIDE MONONITRATE 60 mg/1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-3081-3)
68071-3081-6 68071-3081 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20170314 N/A ANDA ANDA075522 NuCare Pharmaceuticals, Inc. ISOSORBIDE MONONITRATE 60 mg/1 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-3081-6)
68071-3081-9 68071-3081 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20170314 N/A ANDA ANDA075522 NuCare Pharmaceuticals, Inc. ISOSORBIDE MONONITRATE 60 mg/1 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-3081-9)
50090-4009-0 50090-4009 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20181228 N/A ANDA ANDA075522 A-S Medication Solutions ISOSORBIDE MONONITRATE 60 mg/1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-4009-0)
50090-4009-1 50090-4009 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20181228 N/A ANDA ANDA075522 A-S Medication Solutions ISOSORBIDE MONONITRATE 60 mg/1 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (50090-4009-1)
50090-4009-2 50090-4009 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20141128 N/A ANDA ANDA075522 A-S Medication Solutions ISOSORBIDE MONONITRATE 60 mg/1 90 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (50090-4009-2)
71335-2532-3 71335-2532 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20241126 N/A ANDA ANDA075522 Bryant Ranch Prepack ISOSORBIDE MONONITRATE 60 mg/1 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2532-3)
71335-2532-2 71335-2532 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20241126 N/A ANDA ANDA075522 Bryant Ranch Prepack ISOSORBIDE MONONITRATE 60 mg/1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2532-2)
71335-2532-1 71335-2532 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20241126 N/A ANDA ANDA075522 Bryant Ranch Prepack ISOSORBIDE MONONITRATE 60 mg/1 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-2532-1)
62135-586-90 62135-586 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20230426 N/A ANDA ANDA075522 Chartwell RX, LLC ISOSORBIDE MONONITRATE 30 mg/1 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (62135-586-90)
62135-587-90 62135-587 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20230426 N/A ANDA ANDA075522 Chartwell RX, LLC ISOSORBIDE MONONITRATE 60 mg/1 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (62135-587-90)
42799-959-01 42799-959 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20230701 N/A ANDA ANDA075522 Edenbridge Pharmaceuticals LLC. ISOSORBIDE MONONITRATE 60 mg/1 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42799-959-01)
68071-4290-3 68071-4290 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20180219 N/A ANDA ANDA075522 NuCare Pharmaceuticals,Inc. ISOSORBIDE MONONITRATE 30 mg/1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-4290-3)
68071-4290-6 68071-4290 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20180219 N/A ANDA ANDA075522 NuCare Pharmaceuticals,Inc. ISOSORBIDE MONONITRATE 30 mg/1 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-4290-6)
68071-4290-9 68071-4290 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20180219 N/A ANDA ANDA075522 NuCare Pharmaceuticals,Inc. ISOSORBIDE MONONITRATE 30 mg/1 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (68071-4290-9)
42799-959-02 42799-959 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20230701 N/A ANDA ANDA075522 Edenbridge Pharmaceuticals LLC. ISOSORBIDE MONONITRATE 60 mg/1 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42799-959-02)
42799-958-01 42799-958 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20230701 N/A ANDA ANDA075522 Edenbridge Pharmaceuticals LLC. ISOSORBIDE MONONITRATE 30 mg/1 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42799-958-01)
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