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=NDA021951"
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
57664-021-97 57664-021 HUMAN PRESCRIPTION DRUG Isotretinoin Isotretinoin CAPSULE ORAL 20201229 N/A NDA AUTHORIZED GENERIC NDA021951 Sun Pharmaceutical Industries, Inc. ISOTRETINOIN 20 mg/1 3 BLISTER PACK in 1 BOX (57664-021-97) / 10 CAPSULE in 1 BLISTER PACK (57664-021-98)
57664-025-97 57664-025 HUMAN PRESCRIPTION DRUG Isotretinoin Isotretinoin CAPSULE ORAL 20201229 N/A NDA AUTHORIZED GENERIC NDA021951 Sun Pharmaceutical Industries, Inc. ISOTRETINOIN 40 mg/1 3 BLISTER PACK in 1 BOX (57664-025-97) / 10 CAPSULE in 1 BLISTER PACK (57664-025-98)
10631-115-31 10631-115 HUMAN PRESCRIPTION DRUG Absorica isotretinoin CAPSULE ORAL 20120608 N/A NDA NDA021951 Sun Pharmaceutical Industries, Inc. ISOTRETINOIN 10 mg/1 3 BLISTER PACK in 1 BOX (10631-115-31) / 10 CAPSULE in 1 BLISTER PACK (10631-115-69)
10631-133-31 10631-133 HUMAN PRESCRIPTION DRUG Absorica isotretinoin CAPSULE ORAL 20150217 N/A NDA NDA021951 Sun Pharmaceutical Industries, Inc. ISOTRETINOIN 25 mg/1 3 BLISTER PACK in 1 BOX (10631-133-31) / 10 CAPSULE in 1 BLISTER PACK (10631-133-69)
57664-022-97 57664-022 HUMAN PRESCRIPTION DRUG Isotretinoin Isotretinoin CAPSULE ORAL 20201229 N/A NDA AUTHORIZED GENERIC NDA021951 Sun Pharmaceutical Industries, Inc. ISOTRETINOIN 25 mg/1 3 BLISTER PACK in 1 BOX (57664-022-97) / 10 CAPSULE in 1 BLISTER PACK (57664-022-98)
10631-116-31 10631-116 HUMAN PRESCRIPTION DRUG Absorica isotretinoin CAPSULE ORAL 20120608 N/A NDA NDA021951 Sun Pharmaceutical Industries, Inc. ISOTRETINOIN 20 mg/1 3 BLISTER PACK in 1 BOX (10631-116-31) / 10 CAPSULE in 1 BLISTER PACK (10631-116-69)
10631-134-31 10631-134 HUMAN PRESCRIPTION DRUG Absorica isotretinoin CAPSULE ORAL 20150217 N/A NDA NDA021951 Sun Pharmaceutical Industries, Inc. ISOTRETINOIN 35 mg/1 3 BLISTER PACK in 1 BOX (10631-134-31) / 10 CAPSULE in 1 BLISTER PACK (10631-134-69)
57664-023-97 57664-023 HUMAN PRESCRIPTION DRUG Isotretinoin Isotretinoin CAPSULE ORAL 20201229 N/A NDA AUTHORIZED GENERIC NDA021951 Sun Pharmaceutical Industries, Inc. ISOTRETINOIN 30 mg/1 3 BLISTER PACK in 1 BOX (57664-023-97) / 10 CAPSULE in 1 BLISTER PACK (57664-023-98)
10631-117-31 10631-117 HUMAN PRESCRIPTION DRUG Absorica isotretinoin CAPSULE ORAL 20120608 N/A NDA NDA021951 Sun Pharmaceutical Industries, Inc. ISOTRETINOIN 30 mg/1 3 BLISTER PACK in 1 BOX (10631-117-31) / 10 CAPSULE in 1 BLISTER PACK (10631-117-69)
57664-020-97 57664-020 HUMAN PRESCRIPTION DRUG Isotretinoin Isotretinoin CAPSULE ORAL 20201229 N/A NDA AUTHORIZED GENERIC NDA021951 Sun Pharmaceutical Industries, Inc. ISOTRETINOIN 10 mg/1 3 BLISTER PACK in 1 BOX (57664-020-97) / 10 CAPSULE in 1 BLISTER PACK (57664-020-98)
57664-024-97 57664-024 HUMAN PRESCRIPTION DRUG Isotretinoin Isotretinoin CAPSULE ORAL 20201229 N/A NDA AUTHORIZED GENERIC NDA021951 Sun Pharmaceutical Industries, Inc. ISOTRETINOIN 35 mg/1 3 BLISTER PACK in 1 BOX (57664-024-97) / 10 CAPSULE in 1 BLISTER PACK (57664-024-98)
10631-118-31 10631-118 HUMAN PRESCRIPTION DRUG Absorica isotretinoin CAPSULE ORAL 20120608 N/A NDA NDA021951 Sun Pharmaceutical Industries, Inc. ISOTRETINOIN 40 mg/1 3 BLISTER PACK in 1 BOX (10631-118-31) / 10 CAPSULE in 1 BLISTER PACK (10631-118-69)
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