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=ANDA213500"
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
10135-730-01 10135-730 HUMAN PRESCRIPTION DRUG Mexiletine Hydrochloride Mexiletine Hydrochloride CAPSULE ORAL 20220201 N/A ANDA ANDA213500 Marlex Pharmaceuticals, Inc. MEXILETINE HYDROCHLORIDE 150 mg/1 100 CAPSULE in 1 BOTTLE (10135-730-01)
10135-731-01 10135-731 HUMAN PRESCRIPTION DRUG Mexiletine Hydrochloride Mexiletine Hydrochloride CAPSULE ORAL 20220201 N/A ANDA ANDA213500 Marlex Pharmaceuticals, Inc. MEXILETINE HYDROCHLORIDE 200 mg/1 100 CAPSULE in 1 BOTTLE (10135-731-01)
10135-732-01 10135-732 HUMAN PRESCRIPTION DRUG Mexiletine Hydrochloride Mexiletine Hydrochloride CAPSULE ORAL 20220201 N/A ANDA ANDA213500 Marlex Pharmaceuticals, Inc. MEXILETINE HYDROCHLORIDE 250 mg/1 100 CAPSULE in 1 BOTTLE (10135-732-01)
62135-785-90 62135-785 HUMAN PRESCRIPTION DRUG MEXILETINE HYDROCHLORIDE mexiletine hydrochloride CAPSULE ORAL 20231025 N/A ANDA ANDA213500 Chartwell RX, LLC MEXILETINE HYDROCHLORIDE 250 mg/1 90 CAPSULE in 1 BOTTLE (62135-785-90)
0527-4107-37 0527-4107 HUMAN PRESCRIPTION DRUG Mexiletine Hydrochloride Mexiletine Hydrochloride CAPSULE ORAL 20200723 N/A ANDA ANDA213500 Lannett Company, Inc. MEXILETINE HYDROCHLORIDE 150 mg/1 100 CAPSULE in 1 BOTTLE (0527-4107-37)
0527-4108-37 0527-4108 HUMAN PRESCRIPTION DRUG Mexiletine Hydrochloride Mexiletine Hydrochloride CAPSULE ORAL 20200723 N/A ANDA ANDA213500 Lannett Company, Inc. MEXILETINE HYDROCHLORIDE 200 mg/1 100 CAPSULE in 1 BOTTLE (0527-4108-37)
0527-4109-37 0527-4109 HUMAN PRESCRIPTION DRUG Mexiletine Hydrochloride Mexiletine Hydrochloride CAPSULE ORAL 20200723 N/A ANDA ANDA213500 Lannett Company, Inc. MEXILETINE HYDROCHLORIDE 250 mg/1 100 CAPSULE in 1 BOTTLE (0527-4109-37)
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