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=NDA204824"
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
82497-017-04 82497-017 HUMAN PRESCRIPTION DRUG Otrexup methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20240925 N/A NDA NDA204824 Otter Pharmaceuticals, LLC METHOTREXATE 17.5 mg/.4mL 4 SYRINGE in 1 CARTON (82497-017-04) / .4 mL in 1 SYRINGE (82497-017-02)
54436-010-01 54436-010 HUMAN PRESCRIPTION DRUG Otrexup methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20131011 20270430 NDA NDA204824 Antares Pharma, Inc. METHOTREXATE 10 mg/.4mL 1 SYRINGE in 1 CARTON (54436-010-01) / .4 mL in 1 SYRINGE
54436-010-03 54436-010 HUMAN PRESCRIPTION DRUG Otrexup methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20131011 20270430 NDA NDA204824 Antares Pharma, Inc. METHOTREXATE 10 mg/.4mL 1 SYRINGE in 1 CARTON (54436-010-03) / .4 mL in 1 SYRINGE
54436-010-04 54436-010 HUMAN PRESCRIPTION DRUG Otrexup methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20131011 20270430 NDA NDA204824 Antares Pharma, Inc. METHOTREXATE 10 mg/.4mL 4 SYRINGE in 1 CARTON (54436-010-04) / .4 mL in 1 SYRINGE (54436-010-02)
54436-020-01 54436-020 HUMAN PRESCRIPTION DRUG Otrexup methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20131011 20270430 NDA NDA204824 Antares Pharma, Inc. METHOTREXATE 20 mg/.4mL 1 SYRINGE in 1 CARTON (54436-020-01) / .4 mL in 1 SYRINGE
54436-020-03 54436-020 HUMAN PRESCRIPTION DRUG Otrexup methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20131011 20270430 NDA NDA204824 Antares Pharma, Inc. METHOTREXATE 20 mg/.4mL 1 SYRINGE in 1 CARTON (54436-020-03) / .4 mL in 1 SYRINGE
54436-020-04 54436-020 HUMAN PRESCRIPTION DRUG Otrexup methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20131011 20270430 NDA NDA204824 Antares Pharma, Inc. METHOTREXATE 20 mg/.4mL 4 SYRINGE in 1 CARTON (54436-020-04) / .4 mL in 1 SYRINGE (54436-020-02)
82497-010-04 82497-010 HUMAN PRESCRIPTION DRUG Otrexup methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20240925 N/A NDA NDA204824 Otter Pharmaceuticals, LLC METHOTREXATE 10 mg/.4mL 4 SYRINGE in 1 CARTON (82497-010-04) / .4 mL in 1 SYRINGE (82497-010-02)
82497-020-04 82497-020 HUMAN PRESCRIPTION DRUG Otrexup methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20240925 N/A NDA NDA204824 Otter Pharmaceuticals, LLC METHOTREXATE 20 mg/.4mL 4 SYRINGE in 1 CARTON (82497-020-04) / .4 mL in 1 SYRINGE (82497-020-02)
54436-012-01 54436-012 HUMAN PRESCRIPTION DRUG Otrexup methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20160324 20270430 NDA NDA204824 Antares Pharma, Inc. METHOTREXATE 12.5 mg/.4mL 1 SYRINGE in 1 CARTON (54436-012-01) / .4 mL in 1 SYRINGE
54436-012-03 54436-012 HUMAN PRESCRIPTION DRUG Otrexup methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20160324 20270430 NDA NDA204824 Antares Pharma, Inc. METHOTREXATE 12.5 mg/.4mL 1 SYRINGE in 1 CARTON (54436-012-03) / .4 mL in 1 SYRINGE
54436-012-04 54436-012 HUMAN PRESCRIPTION DRUG Otrexup methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20160324 20270430 NDA NDA204824 Antares Pharma, Inc. METHOTREXATE 12.5 mg/.4mL 4 SYRINGE in 1 CARTON (54436-012-04) / .4 mL in 1 SYRINGE (54436-012-02)
54436-022-01 54436-022 HUMAN PRESCRIPTION DRUG Otrexup methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20160324 20270430 NDA NDA204824 Antares Pharma, Inc. METHOTREXATE 22.5 mg/.4mL 1 SYRINGE in 1 CARTON (54436-022-01) / .4 mL in 1 SYRINGE
54436-022-03 54436-022 HUMAN PRESCRIPTION DRUG Otrexup methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20160324 20270430 NDA NDA204824 Antares Pharma, Inc. METHOTREXATE 22.5 mg/.4mL 1 SYRINGE in 1 CARTON (54436-022-03) / .4 mL in 1 SYRINGE
54436-022-04 54436-022 HUMAN PRESCRIPTION DRUG Otrexup methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20160324 20270430 NDA NDA204824 Antares Pharma, Inc. METHOTREXATE 22.5 mg/.4mL 4 SYRINGE in 1 CARTON (54436-022-04) / .4 mL in 1 SYRINGE (54436-022-02)
82497-015-04 82497-015 HUMAN PRESCRIPTION DRUG Otrexup methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20240925 N/A NDA NDA204824 Otter Pharmaceuticals, LLC METHOTREXATE 15 mg/.4mL 4 SYRINGE in 1 CARTON (82497-015-04) / .4 mL in 1 SYRINGE (82497-015-02)
82497-025-04 82497-025 HUMAN PRESCRIPTION DRUG Otrexup methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20240925 N/A NDA NDA204824 Otter Pharmaceuticals, LLC METHOTREXATE 25 mg/.4mL 4 SYRINGE in 1 CARTON (82497-025-04) / .4 mL in 1 SYRINGE (82497-025-02)
54436-017-01 54436-017 HUMAN PRESCRIPTION DRUG Otrexup methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20160324 20270430 NDA NDA204824 Antares Pharma, Inc. METHOTREXATE 17.5 mg/.4mL 1 SYRINGE in 1 CARTON (54436-017-01) / .4 mL in 1 SYRINGE
54436-017-03 54436-017 HUMAN PRESCRIPTION DRUG Otrexup methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20160324 20270430 NDA NDA204824 Antares Pharma, Inc. METHOTREXATE 17.5 mg/.4mL 1 SYRINGE in 1 CARTON (54436-017-03) / .4 mL in 1 SYRINGE
54436-017-04 54436-017 HUMAN PRESCRIPTION DRUG Otrexup methotrexate INJECTION, SOLUTION SUBCUTANEOUS 20160324 20270430 NDA NDA204824 Antares Pharma, Inc. METHOTREXATE 17.5 mg/.4mL 4 SYRINGE in 1 CARTON (54436-017-04) / .4 mL in 1 SYRINGE (54436-017-02)
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