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=ANDA203621"
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
55154-4314-5 55154-4314 HUMAN PRESCRIPTION DRUG Nystatin NYSTATIN SUSPENSION ORAL 20230801 N/A ANDA ANDA203621 Cardinal Health 107, LLC NYSTATIN 100000 [USP'U]/mL 5 CUP, UNIT-DOSE in 1 BAG (55154-4314-5) / 5 mL in 1 CUP, UNIT-DOSE
0904-7276-92 0904-7276 HUMAN PRESCRIPTION DRUG Nystatin NYSTATIN SUSPENSION ORAL 20221128 N/A ANDA ANDA203621 Major Pharmaceuticals NYSTATIN 100000 [USP'U]/mL 5 TRAY in 1 CASE (0904-7276-92) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7276-41)
0904-7276-70 0904-7276 HUMAN PRESCRIPTION DRUG Nystatin NYSTATIN SUSPENSION ORAL 20221128 N/A ANDA ANDA203621 Major Pharmaceuticals NYSTATIN 100000 [USP'U]/mL 10 TRAY in 1 CASE (0904-7276-70) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0904-7276-41)
55154-5788-5 55154-5788 HUMAN PRESCRIPTION DRUG Nystatin NYSTATIN SUSPENSION ORAL 20200717 N/A ANDA ANDA203621 Cardinal Health 107, LLC NYSTATIN 100000 [USP'U]/mL 5 CUP, UNIT-DOSE in 1 BAG (55154-5788-5) / 5 mL in 1 CUP, UNIT-DOSE
63739-160-10 63739-160 HUMAN PRESCRIPTION DRUG Nystatin NYSTATIN SUSPENSION ORAL 20240129 N/A ANDA ANDA203621 McKesson Corporation dba SKY Packaging NYSTATIN 100000 [USP'U]/mL 10 CASE in 1 TRAY (63739-160-10) / 50 CASE in 1 CASE (63739-160-56) / 5 mL in 1 CASE
63739-160-70 63739-160 HUMAN PRESCRIPTION DRUG Nystatin NYSTATIN SUSPENSION ORAL 20240129 N/A ANDA ANDA203621 McKesson Corporation dba SKY Packaging NYSTATIN 100000 [USP'U]/mL 5 mL in 1 CUP, UNIT-DOSE (63739-160-70)
0121-0810-02 0121-0810 HUMAN PRESCRIPTION DRUG Nystatin NYSTATIN SUSPENSION ORAL 20160201 N/A ANDA ANDA203621 Pharmaceutical Associates, Inc. NYSTATIN 100000 [USP'U]/mL 60 mL in 1 BOTTLE, DROPPER (0121-0810-02)
0121-0810-16 0121-0810 HUMAN PRESCRIPTION DRUG Nystatin NYSTATIN SUSPENSION ORAL 20160201 N/A ANDA ANDA203621 Pharmaceutical Associates, Inc. NYSTATIN 100000 [USP'U]/mL 473 mL in 1 BOTTLE (0121-0810-16)
50090-5315-0 50090-5315 HUMAN PRESCRIPTION DRUG Nystatin NYSTATIN SUSPENSION ORAL 20201029 N/A ANDA ANDA203621 A-S Medication Solutions NYSTATIN 100000 [USP'U]/mL 60 mL in 1 BOTTLE, DROPPER (50090-5315-0)
0121-0868-02 0121-0868 HUMAN PRESCRIPTION DRUG Nystatin NYSTATIN SUSPENSION ORAL 20200717 N/A ANDA ANDA203621 PAI Holdings, LLC dba PAI Pharma NYSTATIN 100000 [USP'U]/mL 60 mL in 1 BOTTLE, DROPPER (0121-0868-02)
0121-0868-16 0121-0868 HUMAN PRESCRIPTION DRUG Nystatin NYSTATIN SUSPENSION ORAL 20200717 N/A ANDA ANDA203621 PAI Holdings, LLC dba PAI Pharma NYSTATIN 100000 [USP'U]/mL 473 mL in 1 BOTTLE (0121-0868-16)
0121-0868-00 0121-0868 HUMAN PRESCRIPTION DRUG Nystatin NYSTATIN SUSPENSION ORAL 20200717 N/A ANDA ANDA203621 PAI Holdings, LLC dba PAI Pharma NYSTATIN 100000 [USP'U]/mL 10 TRAY in 1 CASE (0121-0868-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0868-05)
0121-0868-50 0121-0868 HUMAN PRESCRIPTION DRUG Nystatin NYSTATIN SUSPENSION ORAL 20200717 N/A ANDA ANDA203621 PAI Holdings, LLC dba PAI Pharma NYSTATIN 100000 [USP'U]/mL 5 TRAY in 1 CASE (0121-0868-50) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0868-05)
0121-1045-16 0121-1045 HUMAN PRESCRIPTION DRUG Nystatin NYSTATIN SUSPENSION ORAL 20240621 N/A ANDA ANDA203621 PAI Holdings, LLC dba PAI Pharma NYSTATIN 100000 [USP'U]/mL 473 mL in 1 BOTTLE (0121-1045-16)
0121-4810-00 0121-4810 HUMAN PRESCRIPTION DRUG Nystatin NYSTATIN SUSPENSION ORAL 20160201 N/A ANDA ANDA203621 Pharmaceutical Associates, Inc. NYSTATIN 100000 [USP'U]/mL 10 TRAY in 1 CASE (0121-4810-00) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE
0121-4810-40 0121-4810 HUMAN PRESCRIPTION DRUG Nystatin NYSTATIN SUSPENSION ORAL 20160201 N/A ANDA ANDA203621 Pharmaceutical Associates, Inc. NYSTATIN 100000 [USP'U]/mL 4 TRAY in 1 CASE (0121-4810-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-4810-05)
0121-4810-50 0121-4810 HUMAN PRESCRIPTION DRUG Nystatin NYSTATIN SUSPENSION ORAL 20200626 N/A ANDA ANDA203621 Pharmaceutical Associates, Inc. NYSTATIN 100000 [USP'U]/mL 5 PACKAGE in 1 CASE (0121-4810-50) / 10 CUP, UNIT-DOSE in 1 PACKAGE / 5 mL in 1 CUP, UNIT-DOSE
60687-800-17 60687-800 HUMAN PRESCRIPTION DRUG Nystatin Nystatin SUSPENSION ORAL 20240226 N/A ANDA ANDA203621 American Health Packaging NYSTATIN 100000 [USP'U]/mL 10 TRAY in 1 CASE (60687-800-17) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-800-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-800-40)
67296-2118-6 67296-2118 HUMAN PRESCRIPTION DRUG Nystatin NYSTATIN SUSPENSION ORAL 20200717 N/A ANDA ANDA203621 RedPharm Drug NYSTATIN 100000 [USP'U]/mL 60 mL in 1 BOTTLE (67296-2118-6)
17856-1045-5 17856-1045 HUMAN PRESCRIPTION DRUG Nystatin NYSTATIN SUSPENSION ORAL 20240718 N/A ANDA ANDA203621 ATLANTIC BIOLOGICALS CORP. NYSTATIN 100000 [USP'U]/mL 48 SYRINGE in 1 BOX, UNIT-DOSE (17856-1045-5) / 5 mL in 1 SYRINGE (17856-1045-6)
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