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
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)
42799-958-02 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/1 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (42799-958-02)
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)
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)
70934-972-30 70934-972 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20220525 20240831 ANDA ANDA075522 Denton Pharma, Inc. DBA Northwind Pharmaceuticals ISOSORBIDE MONONITRATE 60 mg/1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (70934-972-30)
70518-2122-0 70518-2122 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20190529 N/A ANDA ANDA075522 REMEDYREPACK INC. ISOSORBIDE MONONITRATE 30 mg/1 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-2122-0)
71335-1117-1 71335-1117 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20220209 N/A ANDA ANDA075522 Bryant Ranch Prepack ISOSORBIDE MONONITRATE 30 mg/1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1117-1)
71335-1117-2 71335-1117 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20220209 N/A ANDA ANDA075522 Bryant Ranch Prepack ISOSORBIDE MONONITRATE 30 mg/1 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1117-2)
71335-1117-3 71335-1117 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20220209 N/A ANDA ANDA075522 Bryant Ranch Prepack ISOSORBIDE MONONITRATE 30 mg/1 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1117-3)
71335-1117-4 71335-1117 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20220209 N/A ANDA ANDA075522 Bryant Ranch Prepack ISOSORBIDE MONONITRATE 30 mg/1 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1117-4)
71335-1117-5 71335-1117 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20220209 N/A ANDA ANDA075522 Bryant Ranch Prepack ISOSORBIDE MONONITRATE 30 mg/1 10 TABLET, EXTENDED RELEASE in 1 BOTTLE (71335-1117-5)
23155-178-01 23155-178 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20100607 N/A ANDA ANDA075522 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. ISOSORBIDE MONONITRATE 60 mg/1 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-178-01)
23155-178-05 23155-178 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20100607 N/A ANDA ANDA075522 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. ISOSORBIDE MONONITRATE 60 mg/1 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-178-05)
23155-178-09 23155-178 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20100607 N/A ANDA ANDA075522 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. ISOSORBIDE MONONITRATE 60 mg/1 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-178-09)
23155-519-01 23155-519 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20170105 N/A ANDA ANDA075522 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. ISOSORBIDE MONONITRATE 30 mg/1 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-519-01)
23155-519-03 23155-519 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20170105 N/A ANDA ANDA075522 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. ISOSORBIDE MONONITRATE 30 mg/1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-519-03)
23155-519-05 23155-519 HUMAN PRESCRIPTION DRUG Isosorbide Mononitrate Isosorbide Mononitrate TABLET, EXTENDED RELEASE ORAL 20170105 N/A ANDA ANDA075522 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. ISOSORBIDE MONONITRATE 30 mg/1 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-519-05)
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)
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