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=NDA021135"
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
0517-2325-10 0517-2325 HUMAN PRESCRIPTION DRUG Venofer iron sucrose INJECTION, SOLUTION INTRAVENOUS 20110127 N/A NDA NDA021135 American Regent, Inc. IRON SUCROSE 20 mg/mL 10 VIAL, SINGLE-DOSE in 1 BOX (0517-2325-10) / 2.5 mL in 1 VIAL, SINGLE-DOSE (0517-2325-01)
0517-2310-05 0517-2310 HUMAN PRESCRIPTION DRUG Venofer iron sucrose INJECTION, SOLUTION INTRAVENOUS 20070612 N/A NDA NDA021135 American Regent, Inc. IRON SUCROSE 20 mg/mL 5 VIAL, SINGLE-DOSE in 1 BOX (0517-2310-05) / 10 mL in 1 VIAL, SINGLE-DOSE (0517-2310-01)
0517-2340-01 0517-2340 HUMAN PRESCRIPTION DRUG Venofer iron sucrose INJECTION, SOLUTION INTRAVENOUS 20001110 N/A NDA NDA021135 American Regent, Inc. IRON SUCROSE 20 mg/mL 1 VIAL, SINGLE-DOSE in 1 BOX (0517-2340-01) / 5 mL in 1 VIAL, SINGLE-DOSE
0517-2340-10 0517-2340 HUMAN PRESCRIPTION DRUG Venofer iron sucrose INJECTION, SOLUTION INTRAVENOUS 20001110 N/A NDA NDA021135 American Regent, Inc. IRON SUCROSE 20 mg/mL 10 VIAL, SINGLE-DOSE in 1 BOX (0517-2340-10) / 5 mL in 1 VIAL, SINGLE-DOSE
0517-2340-25 0517-2340 HUMAN PRESCRIPTION DRUG Venofer iron sucrose INJECTION, SOLUTION INTRAVENOUS 20001110 N/A NDA NDA021135 American Regent, Inc. IRON SUCROSE 20 mg/mL 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-2340-25) / 5 mL in 1 VIAL, SINGLE-DOSE
49230-530-10 49230-530 HUMAN PRESCRIPTION DRUG Venofer iron sucrose INJECTION, SOLUTION INTRAVENOUS 20110127 N/A NDA AUTHORIZED GENERIC NDA021135 Fresenius Medical Care Holdings, Inc. IRON SUCROSE 20 mg/mL 10 VIAL, SINGLE-DOSE in 1 BOX (49230-530-10) / 2.5 mL in 1 VIAL, SINGLE-DOSE (49230-530-01)
49230-530-25 49230-530 HUMAN PRESCRIPTION DRUG Venofer iron sucrose INJECTION, SOLUTION INTRAVENOUS 20110127 N/A NDA AUTHORIZED GENERIC NDA021135 Fresenius Medical Care Holdings, Inc. IRON SUCROSE 20 mg/mL 25 VIAL, SINGLE-DOSE in 1 TRAY (49230-530-25) / 2.5 mL in 1 VIAL, SINGLE-DOSE (49230-530-01)
51662-1568-3 51662-1568 HUMAN PRESCRIPTION DRUG VENOFER (IRON SUCROSE) VENOFER (IRON SUCROSE) INJECTION, SOLUTION INTRAVENOUS 20210625 N/A NDA NDA021135 HF Acquisition Co LLC, DBA HealthFirst IRON SUCROSE 20 mg/mL 10 POUCH in 1 CASE (51662-1568-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1568-2) / 5 mL in 1 VIAL, SINGLE-DOSE (51662-1568-1)
0517-2340-99 0517-2340 HUMAN PRESCRIPTION DRUG Venofer iron sucrose INJECTION, SOLUTION INTRAVENOUS 20140714 N/A NDA NDA021135 American Regent, Inc. IRON SUCROSE 20 mg/mL 10 VIAL, SINGLE-DOSE in 1 CARTON (0517-2340-99) / 5 mL in 1 VIAL, SINGLE-DOSE
49230-534-10 49230-534 HUMAN PRESCRIPTION DRUG Venofer iron sucrose INJECTION, SOLUTION INTRAVENOUS 20081104 N/A NDA NDA021135 Fresenius Medical Care Holdings, Inc. IRON SUCROSE 20 mg/mL 10 VIAL, SINGLE-DOSE in 1 BOX (49230-534-10) / 5 mL in 1 VIAL, SINGLE-DOSE (49230-534-01)
49230-534-25 49230-534 HUMAN PRESCRIPTION DRUG Venofer iron sucrose INJECTION, SOLUTION INTRAVENOUS 20081104 N/A NDA NDA021135 Fresenius Medical Care Holdings, Inc. IRON SUCROSE 20 mg/mL 25 VIAL, SINGLE-DOSE in 1 TRAY (49230-534-25) / 5 mL in 1 VIAL, SINGLE-DOSE (49230-534-01)
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