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=ANDA208947"
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
34908-636-10 34908-636 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20170831 N/A ANDA ANDA208947 Novast Laboratories, Ltd. QUETIAPINE FUMARATE 150 mg/1 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (34908-636-10)
34908-636-30 34908-636 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20170831 N/A ANDA ANDA208947 Novast Laboratories, Ltd. QUETIAPINE FUMARATE 150 mg/1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (34908-636-30)
34908-636-60 34908-636 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20170831 N/A ANDA ANDA208947 Novast Laboratories, Ltd. QUETIAPINE FUMARATE 150 mg/1 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (34908-636-60)
34908-636-90 34908-636 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20170831 N/A ANDA ANDA208947 Novast Laboratories, Ltd. QUETIAPINE FUMARATE 150 mg/1 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (34908-636-90)
34908-637-10 34908-637 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20170831 N/A ANDA ANDA208947 Novast Laboratories, Ltd. QUETIAPINE FUMARATE 200 mg/1 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (34908-637-10)
34908-637-30 34908-637 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20170831 N/A ANDA ANDA208947 Novast Laboratories, Ltd. QUETIAPINE FUMARATE 200 mg/1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (34908-637-30)
34908-637-60 34908-637 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20170831 N/A ANDA ANDA208947 Novast Laboratories, Ltd. QUETIAPINE FUMARATE 200 mg/1 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (34908-637-60)
34908-637-90 34908-637 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20170831 N/A ANDA ANDA208947 Novast Laboratories, Ltd. QUETIAPINE FUMARATE 200 mg/1 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (34908-637-90)
34908-638-10 34908-638 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20170831 N/A ANDA ANDA208947 Novast Laboratories, Ltd. QUETIAPINE FUMARATE 300 mg/1 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (34908-638-10)
34908-638-30 34908-638 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20170831 N/A ANDA ANDA208947 Novast Laboratories, Ltd. QUETIAPINE FUMARATE 300 mg/1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (34908-638-30)
34908-638-60 34908-638 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20170831 N/A ANDA ANDA208947 Novast Laboratories, Ltd. QUETIAPINE FUMARATE 300 mg/1 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (34908-638-60)
34908-638-90 34908-638 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20170831 N/A ANDA ANDA208947 Novast Laboratories, Ltd. QUETIAPINE FUMARATE 300 mg/1 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (34908-638-90)
34908-639-10 34908-639 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20170831 N/A ANDA ANDA208947 Novast Laboratories, Ltd. QUETIAPINE FUMARATE 400 mg/1 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (34908-639-10)
34908-639-30 34908-639 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20170831 N/A ANDA ANDA208947 Novast Laboratories, Ltd. QUETIAPINE FUMARATE 400 mg/1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (34908-639-30)
34908-639-60 34908-639 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20170831 N/A ANDA ANDA208947 Novast Laboratories, Ltd. QUETIAPINE FUMARATE 400 mg/1 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (34908-639-60)
34908-639-90 34908-639 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20170831 N/A ANDA ANDA208947 Novast Laboratories, Ltd. QUETIAPINE FUMARATE 400 mg/1 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (34908-639-90)
50742-635-10 50742-635 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20170831 N/A ANDA ANDA208947 Ingenus Pharmaceuticals, LLC QUETIAPINE FUMARATE 50 mg/1 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-635-10)
50742-635-30 50742-635 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20170831 N/A ANDA ANDA208947 Ingenus Pharmaceuticals, LLC QUETIAPINE FUMARATE 50 mg/1 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-635-30)
50742-635-60 50742-635 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20170831 N/A ANDA ANDA208947 Ingenus Pharmaceuticals, LLC QUETIAPINE FUMARATE 50 mg/1 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-635-60)
50742-635-90 50742-635 HUMAN PRESCRIPTION DRUG Quetiapine Fumarate quetiapine fumarate TABLET, EXTENDED RELEASE ORAL 20170831 N/A ANDA ANDA208947 Ingenus Pharmaceuticals, LLC QUETIAPINE FUMARATE 50 mg/1 90 TABLET, EXTENDED RELEASE in 1 BOTTLE (50742-635-90)
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