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=ANDA202891"
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
68382-474-06 68382-474 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET, EXTENDED RELEASE ORAL 20180424 N/A ANDA ANDA202891 Zydus Pharmaceuticals USA Inc. PRAMIPEXOLE DIHYDROCHLORIDE .375 mg/1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-474-06)
68382-474-77 68382-474 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET, EXTENDED RELEASE ORAL 20180424 N/A ANDA ANDA202891 Zydus Pharmaceuticals USA Inc. PRAMIPEXOLE DIHYDROCHLORIDE .375 mg/1 10 BLISTER PACK in 1 CARTON (68382-474-77) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68382-474-30)
68382-475-06 68382-475 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET, EXTENDED RELEASE ORAL 20180424 N/A ANDA ANDA202891 Zydus Pharmaceuticals USA Inc. PRAMIPEXOLE DIHYDROCHLORIDE .75 mg/1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-475-06)
68382-475-77 68382-475 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET, EXTENDED RELEASE ORAL 20180424 N/A ANDA ANDA202891 Zydus Pharmaceuticals USA Inc. PRAMIPEXOLE DIHYDROCHLORIDE .75 mg/1 10 BLISTER PACK in 1 CARTON (68382-475-77) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68382-475-30)
68382-476-06 68382-476 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET, EXTENDED RELEASE ORAL 20180424 N/A ANDA ANDA202891 Zydus Pharmaceuticals USA Inc. PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-476-06)
68382-476-77 68382-476 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET, EXTENDED RELEASE ORAL 20180424 N/A ANDA ANDA202891 Zydus Pharmaceuticals USA Inc. PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 10 BLISTER PACK in 1 CARTON (68382-476-77) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68382-476-30)
68382-477-06 68382-477 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET, EXTENDED RELEASE ORAL 20180424 N/A ANDA ANDA202891 Zydus Pharmaceuticals USA Inc. PRAMIPEXOLE DIHYDROCHLORIDE 3 mg/1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-477-06)
68382-477-77 68382-477 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET, EXTENDED RELEASE ORAL 20180424 N/A ANDA ANDA202891 Zydus Pharmaceuticals USA Inc. PRAMIPEXOLE DIHYDROCHLORIDE 3 mg/1 10 BLISTER PACK in 1 CARTON (68382-477-77) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68382-477-30)
68382-478-06 68382-478 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET, EXTENDED RELEASE ORAL 20180424 N/A ANDA ANDA202891 Zydus Pharmaceuticals USA Inc. PRAMIPEXOLE DIHYDROCHLORIDE 4.5 mg/1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-478-06)
68382-478-77 68382-478 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET, EXTENDED RELEASE ORAL 20180424 N/A ANDA ANDA202891 Zydus Pharmaceuticals USA Inc. PRAMIPEXOLE DIHYDROCHLORIDE 4.5 mg/1 10 BLISTER PACK in 1 CARTON (68382-478-77) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68382-478-30)
68382-874-06 68382-874 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET, EXTENDED RELEASE ORAL 20180424 N/A ANDA ANDA202891 Zydus Pharmaceuticals USA Inc. PRAMIPEXOLE DIHYDROCHLORIDE 2.25 mg/1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-874-06)
68382-875-06 68382-875 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET, EXTENDED RELEASE ORAL 20180424 N/A ANDA ANDA202891 Zydus Pharmaceuticals USA Inc. PRAMIPEXOLE DIHYDROCHLORIDE 3.75 mg/1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (68382-875-06)
68382-875-77 68382-875 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET, EXTENDED RELEASE ORAL 20180424 N/A ANDA ANDA202891 Zydus Pharmaceuticals USA Inc. PRAMIPEXOLE DIHYDROCHLORIDE 3.75 mg/1 10 BLISTER PACK in 1 CARTON (68382-875-77) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (68382-875-30)
70771-1328-3 70771-1328 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET, EXTENDED RELEASE ORAL 20180424 N/A ANDA ANDA202891 Zydus Lifesciences Limited PRAMIPEXOLE DIHYDROCHLORIDE .375 mg/1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1328-3)
70771-1328-4 70771-1328 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET, EXTENDED RELEASE ORAL 20180424 N/A ANDA ANDA202891 Zydus Lifesciences Limited PRAMIPEXOLE DIHYDROCHLORIDE .375 mg/1 10 BLISTER PACK in 1 CARTON (70771-1328-4) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70771-1328-2)
70771-1329-3 70771-1329 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET, EXTENDED RELEASE ORAL 20180424 N/A ANDA ANDA202891 Zydus Lifesciences Limited PRAMIPEXOLE DIHYDROCHLORIDE .75 mg/1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1329-3)
70771-1329-4 70771-1329 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET, EXTENDED RELEASE ORAL 20180424 N/A ANDA ANDA202891 Zydus Lifesciences Limited PRAMIPEXOLE DIHYDROCHLORIDE .75 mg/1 10 BLISTER PACK in 1 CARTON (70771-1329-4) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70771-1329-2)
70771-1330-3 70771-1330 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET, EXTENDED RELEASE ORAL 20180424 N/A ANDA ANDA202891 Zydus Lifesciences Limited PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1330-3)
70771-1330-4 70771-1330 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET, EXTENDED RELEASE ORAL 20180424 N/A ANDA ANDA202891 Zydus Lifesciences Limited PRAMIPEXOLE DIHYDROCHLORIDE 1.5 mg/1 10 BLISTER PACK in 1 CARTON (70771-1330-4) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70771-1330-2)
70771-1331-3 70771-1331 HUMAN PRESCRIPTION DRUG Pramipexole Dihydrochloride Pramipexole Dihydrochloride TABLET, EXTENDED RELEASE ORAL 20180424 N/A ANDA ANDA202891 Zydus Lifesciences Limited PRAMIPEXOLE DIHYDROCHLORIDE 2.25 mg/1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (70771-1331-3)
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