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=NDA005213"
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
64950-205-03 64950-205 HUMAN PRESCRIPTION DRUG Hycodan Hydrocodone Bitartrate and Homatropine Methylbromide TABLET ORAL 20211101 N/A NDA NDA005213 Genus Lifesciences Inc. HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE 1.5 mg/1; 5 mg/1 30 TABLET in 1 BOTTLE, PLASTIC (64950-205-03)
64950-205-10 64950-205 HUMAN PRESCRIPTION DRUG Hycodan Hydrocodone Bitartrate and Homatropine Methylbromide TABLET ORAL 20211101 N/A NDA NDA005213 Genus Lifesciences Inc. HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE 1.5 mg/1; 5 mg/1 100 TABLET in 1 BOTTLE, PLASTIC (64950-205-10)
64950-342-45 64950-342 HUMAN PRESCRIPTION DRUG Hycodan Hydrocodone Bitartrate and Homatropine Methylbromide SOLUTION ORAL 20191216 N/A NDA NDA005213 Genus Lifesciences Inc. HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE 1.5 mg/5mL; 5 mg/5mL 40 CUP, UNIT-DOSE in 1 CASE (64950-342-45) / 5 mL in 1 CUP, UNIT-DOSE (64950-342-05)
64950-342-47 64950-342 HUMAN PRESCRIPTION DRUG Hycodan Hydrocodone Bitartrate and Homatropine Methylbromide SOLUTION ORAL 20190614 N/A NDA NDA005213 Genus Lifesciences Inc. HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE 1.5 mg/5mL; 5 mg/5mL 473 mL in 1 BOTTLE (64950-342-47)
64950-371-47 64950-371 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Homatropine Methylbromide Hydrocodone Bitartrate and Homatropine Methylbromide SOLUTION ORAL 20220810 N/A NDA AUTHORIZED GENERIC NDA005213 Genus Lifesciences Inc. HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE 1.5 mg/5mL; 5 mg/5mL 473 mL in 1 BOTTLE (64950-371-47)
64950-206-03 64950-206 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Homatropine Methylbromide Hydrocodone Bitartrate and Homatropine Methylbromide TABLET ORAL 20220810 N/A NDA AUTHORIZED GENERIC NDA005213 Genus Lifesciences Inc. HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE 1.5 mg/1; 5 mg/1 30 TABLET in 1 BOTTLE, PLASTIC (64950-206-03)
64950-206-10 64950-206 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Homatropine Methylbromide Hydrocodone Bitartrate and Homatropine Methylbromide TABLET ORAL 20220810 N/A NDA AUTHORIZED GENERIC NDA005213 Genus Lifesciences Inc. HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE 1.5 mg/1; 5 mg/1 100 TABLET in 1 BOTTLE, PLASTIC (64950-206-10)
0121-1036-40 0121-1036 HUMAN PRESCRIPTION DRUG Hydrocodone Bitartrate and Homatropine Methylbromide Hydrocodone Bitartrate and Homatropine Methylbromide SOLUTION ORAL 20240805 N/A NDA AUTHORIZED GENERIC NDA005213 PAI Holdings, LLC dba PAI Pharma HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE 1.5 mg/5mL; 5 mg/5mL 4 TRAY in 1 CASE (0121-1036-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-1036-05)
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