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=ANDA076485"
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
68308-781-30 68308-781 HUMAN PRESCRIPTION DRUG Isotretinoin Isotretinoin CAPSULE, LIQUID FILLED ORAL 20231201 N/A ANDA ANDA076485 Mayne Pharma ISOTRETINOIN 10 mg/1 3 BLISTER PACK in 1 BOX (68308-781-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68308-781-01)
68308-782-30 68308-782 HUMAN PRESCRIPTION DRUG Isotretinoin Isotretinoin CAPSULE, LIQUID FILLED ORAL 20231201 N/A ANDA ANDA076485 Mayne Pharma ISOTRETINOIN 20 mg/1 3 BLISTER PACK in 1 BOX (68308-782-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68308-782-01)
68308-783-30 68308-783 HUMAN PRESCRIPTION DRUG Isotretinoin Isotretinoin CAPSULE, LIQUID FILLED ORAL 20231201 N/A ANDA ANDA076485 Mayne Pharma ISOTRETINOIN 30 mg/1 3 BLISTER PACK in 1 BOX (68308-783-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68308-783-01)
68308-784-30 68308-784 HUMAN PRESCRIPTION DRUG Isotretinoin Isotretinoin CAPSULE, LIQUID FILLED ORAL 20231201 N/A ANDA ANDA076485 Mayne Pharma ISOTRETINOIN 40 mg/1 3 BLISTER PACK in 1 BOX (68308-784-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (68308-784-01)
0832-8301-30 0832-8301 HUMAN PRESCRIPTION DRUG Isotretinoin Isotretinoin CAPSULE, LIQUID FILLED ORAL 20230606 N/A ANDA ANDA076485 Upsher-Smith Laboratories, LLC ISOTRETINOIN 10 mg/1 3 BLISTER PACK in 1 BOX (0832-8301-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0832-8301-89)
0832-8302-30 0832-8302 HUMAN PRESCRIPTION DRUG Isotretinoin Isotretinoin CAPSULE, LIQUID FILLED ORAL 20230606 N/A ANDA ANDA076485 Upsher-Smith Laboratories, LLC ISOTRETINOIN 20 mg/1 3 BLISTER PACK in 1 BOX (0832-8302-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0832-8302-89)
0832-8303-30 0832-8303 HUMAN PRESCRIPTION DRUG Isotretinoin Isotretinoin CAPSULE, LIQUID FILLED ORAL 20230606 N/A ANDA ANDA076485 Upsher-Smith Laboratories, LLC ISOTRETINOIN 30 mg/1 3 BLISTER PACK in 1 BOX (0832-8303-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0832-8303-89)
0832-8304-30 0832-8304 HUMAN PRESCRIPTION DRUG Isotretinoin Isotretinoin CAPSULE, LIQUID FILLED ORAL 20230606 N/A ANDA ANDA076485 Upsher-Smith Laboratories, LLC ISOTRETINOIN 40 mg/1 3 BLISTER PACK in 1 BOX (0832-8304-30) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0832-8304-89)
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