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=ANDA089763"
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
42291-922-01 42291-922 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20230413 N/A ANDA ANDA089763 AvKARE THEOPHYLLINE ANHYDROUS 300 mg/1 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (42291-922-01)
62135-457-90 62135-457 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20230212 N/A ANDA ANDA089763 Chartwell RX, LLC THEOPHYLLINE ANHYDROUS 300 mg/1 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (62135-457-90)
23155-741-05 23155-741 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20220627 N/A ANDA ANDA089763 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. THEOPHYLLINE ANHYDROUS 300 mg/1 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-741-05)
23155-741-01 23155-741 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20220627 N/A ANDA ANDA089763 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. THEOPHYLLINE ANHYDROUS 300 mg/1 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-741-01)
23155-741-10 23155-741 HUMAN PRESCRIPTION DRUG Theophylline Theophylline TABLET, EXTENDED RELEASE ORAL 20220627 N/A ANDA ANDA089763 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. THEOPHYLLINE ANHYDROUS 300 mg/1 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (23155-741-10)
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