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=NDA012462"
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
43353-083-30 43353-083 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate DIPHENOXYLATE HYDROCHLORIDE and ATROPINE SULFATE TABLET ORAL 20150713 N/A NDA AUTHORIZED GENERIC NDA012462 Aphena Pharma Solutions - Tennessee, LLC ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025 mg/1; 2.5 mg/1 30 TABLET in 1 BOTTLE (43353-083-30)
43353-083-53 43353-083 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate DIPHENOXYLATE HYDROCHLORIDE and ATROPINE SULFATE TABLET ORAL 20150714 N/A NDA AUTHORIZED GENERIC NDA012462 Aphena Pharma Solutions - Tennessee, LLC ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025 mg/1; 2.5 mg/1 60 TABLET in 1 BOTTLE (43353-083-53)
43353-083-60 43353-083 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate DIPHENOXYLATE HYDROCHLORIDE and ATROPINE SULFATE TABLET ORAL 20150713 N/A NDA AUTHORIZED GENERIC NDA012462 Aphena Pharma Solutions - Tennessee, LLC ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025 mg/1; 2.5 mg/1 90 TABLET in 1 BOTTLE (43353-083-60)
43353-083-70 43353-083 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate DIPHENOXYLATE HYDROCHLORIDE and ATROPINE SULFATE TABLET ORAL 20150713 N/A NDA AUTHORIZED GENERIC NDA012462 Aphena Pharma Solutions - Tennessee, LLC ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025 mg/1; 2.5 mg/1 120 TABLET in 1 BOTTLE (43353-083-70)
43353-083-80 43353-083 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate DIPHENOXYLATE HYDROCHLORIDE and ATROPINE SULFATE TABLET ORAL 20150815 N/A NDA AUTHORIZED GENERIC NDA012462 Aphena Pharma Solutions - Tennessee, LLC ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025 mg/1; 2.5 mg/1 180 TABLET in 1 BOTTLE (43353-083-80)
43353-083-90 43353-083 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate DIPHENOXYLATE HYDROCHLORIDE and ATROPINE SULFATE TABLET ORAL 20150727 N/A NDA AUTHORIZED GENERIC NDA012462 Aphena Pharma Solutions - Tennessee, LLC ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025 mg/1; 2.5 mg/1 240 TABLET in 1 BOTTLE (43353-083-90)
59762-1061-1 59762-1061 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate Diphenoxylate Hydrochloride and Atropine Sulfate TABLET ORAL 20120807 N/A NDA AUTHORIZED GENERIC NDA012462 Greenstone LLC ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025 mg/1; 2.5 mg/1 100 TABLET in 1 BOTTLE (59762-1061-1)
59762-1061-2 59762-1061 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate Diphenoxylate Hydrochloride and Atropine Sulfate TABLET ORAL 20130306 N/A NDA AUTHORIZED GENERIC NDA012462 Greenstone LLC ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025 mg/1; 2.5 mg/1 1000 TABLET in 1 BOTTLE (59762-1061-2)
70518-2135-0 70518-2135 HUMAN PRESCRIPTION DRUG Diphenoxylate Hydrochloride and Atropine Sulfate Diphenoxylate Hydrochloride and Atropine Sulfate TABLET ORAL 20190607 N/A NDA AUTHORIZED GENERIC NDA012462 REMEDYREPACK INC. ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025 mg/1; 2.5 mg/1 30 TABLET in 1 BLISTER PACK (70518-2135-0)
0025-0061-31 0025-0061 HUMAN PRESCRIPTION DRUG Lomotil diphenoxylate hydrochloride and atropine sulfate TABLET ORAL 19600915 N/A NDA NDA012462 Pfizer Laboratories Div Pfizer Inc ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE .025 mg/1; 2.5 mg/1 100 TABLET in 1 BOTTLE (0025-0061-31)
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