FDA.reportPublic FDA data

Application 077851

Type
ANDA
Sponsor
NATCO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDETABLET;ORALEQ 4MG BASENoNo
002ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDETABLET;ORALEQ 8MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0179-0099ondansetronondansetron hydrochlorideKAISER FOUNDATION HOSPITALSANDACurrent
0179-0100ondansetronondansetron hydrochlorideKAISER FOUNDATION HOSPITALSANDACurrent
35356-853OndansetronOndansetronLake Erie Medical DBA QuaANDACurrent
35356-853OndansetronOndansetronLake Erie Medical DBA Quality Care Products LLCANDACurrent
43063-746ondansetronondansetron hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-746ondansetronondansetron hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-746ondansetronondansetron hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-746ondansetronondansetron hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-746ondansetronondansetron hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
45963-538OndansetronOndansetronACTAVIS PHARMA, INC.ANDACurrent
45963-538OndansetronOndansetronACTAVIS PHARMA, INC.ANDACurrent
45963-539OndansetronOndansetronACTAVIS PHARMA, INC.ANDACurrent
45963-539OndansetronOndansetronACTAVIS PHARMA, INC.ANDACurrent
50090-1600ondansetronondansetron hydrochlorideA-S Medication SolutionsANDACurrent
50090-3769ONDANSETRONONDANSETRONA-S Medication SolutionsANDACurrent
50436-0132ondansetronondansetron hydrochlorideUnit Dose ServicesANDACurrent
50436-0459ONDANSETRONONDANSETRONUnit Dose ServicesANDACurrent
51655-400Ondansetron HCLOndansetron HCLNorthwind PharmaceuticalsANDACurrent
51655-800ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDENorthwind PharmaceuticalsANDACurrent
51655-803ONDANSETRONondansetron hydrochlorideNorthwind Pharmaceuticals, LLCANDACurrent
53002-0570OndansetronOndansetronRPK Pharmaceuticals, Inc.ANDACurrent
53002-0570OndansetronOndansetronRPK Pharmaceuticals, Inc.ANDACurrent
53002-0600ondansetronondansetron hydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-0600ondansetronondansetron hydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53217-300ondansetronondansetron hydrochlorideAidarex Pharmaceuticals LLCANDACurrent
55700-064ONDANSETRONONDANSETRONLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-484OndansetronOndansetronLake Erie Medical DBA Quality Care Products LLCANDACurrent
58118-0450ONDANSETRONONDANSETRONClinical Solutions Wholesale, LLCANDACurrent
60687-636OndansetronOndansetronAmerican Health PackagingANDACurrent
60687-647OndansetronOndansetronAmerican Health PackagingANDACurrent
61919-464ONDANSETRONONDANSETRONDIRECT RXANDACurrent
61919-465ONDANSETRON HYDROCHLORIDEONDANSETRON HYDROCHLORIDEDIRECT RXANDACurrent
63187-065ONDANSETRONONDANSETRONProficient Rx LPANDACurrent
63187-065ONDANSETRONONDANSETRONProficient Rx LPANDACurrent
63187-236ONDANSETRONONDANSETRONProficient Rx LPANDACurrent
63187-236ONDANSETRONONDANSETRONProficient Rx LPANDACurrent
63187-513ondansetronondansetron hydrochlorideProficient Rx LPANDACurrent
63187-513ondansetronondansetron hydrochlorideProficient Rx LPANDACurrent
63304-458ONDANSETRONONDANSETRONRanbaxy Pharmaceuticals Inc.ANDACurrent
63304-458ONDANSETRONONDANSETRONSun Pharmaceutical Industries, Inc.ANDACurrent
63304-459ONDANSETRONONDANSETRONSun Pharmaceutical Industries, Inc.ANDACurrent
63304-459ONDANSETRONONDANSETRONRanbaxy Pharmaceuticals Inc.ANDACurrent
63739-333OndansetronOndansetronMcKesson Corporation dba SKY PackagingANDACurrent
63739-333OndansetronOndansetronMcKesson Corporation dba SKY PackagingANDACurrent
63739-333OndansetronOndansetronMcKesson Corporation dba SKY PackagingANDACurrent
63850-0003OndansetronOndansetron TabletsNatco Pharma LimitedANDACurrent
63850-0003OndansetronOndansetron TabletsNatco Pharma LimitedANDACurrent
63850-0004OndansetronOndansetron TabletsNatco Pharma LimitedANDACurrent
63850-0004OndansetronOndansetron TabletsNatco Pharma LimitedANDACurrent
65084-333OndansetronOndansetronMcKesson Corporation dba RX PakANDACurrent
67296-1294ondansetronondansetronRedPharm Drug, Inc.ANDACurrent
67296-1294ondansetronondansetronRedPharm Drug, Inc.ANDACurrent
67296-1294ondansetronondansetronRedPharm Drug, Inc.ANDACurrent
67877-169ondansetronondansetron hydrochlorideAscend Laboratories, LLCANDACurrent
67877-170ondansetronondansetron hydrochlorideAscend Laboratories, LLCANDACurrent
68071-4529ondansetronondansetron hydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-9892ondansetron hydrochlorideondansetron hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9893ondansetron hydrochlorideondansetron hydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
69339-171OndansetronOndansetronDASH Pharmaceuticals LLCANDACurrent
69339-172OndansetronOndansetronDASH Pharmaceuticals LLCANDACurrent
70518-0021ONDANSETRONONDANSETRONREMEDYREPACK INC.ANDACurrent
70518-0480OndansetronOndansetronREMEDYREPACK INC.ANDACurrent
70518-0480OndansetronOndansetronREMEDYREPACK INC.ANDACurrent
70518-0892OndansetronOndansetronREMEDYREPACK INC.ANDACurrent
70518-0892OndansetronOndansetronREMEDYREPACK INC.ANDACurrent
70518-0892OndansetronOndansetronREMEDYREPACK INC.ANDACurrent
71335-0132OndansetronOndansetronBryant Ranch PrepackANDACurrent
71335-0132OndansetronOndansetronBryant Ranch PrepackANDACurrent
71335-0815ondansetronondansetron hydrochlorideBryant Ranch PrepackANDACurrent
71335-0815ondansetronondansetron hydrochlorideBryant Ranch PrepackANDACurrent
71335-0816ondansetronondansetron hydrochlorideBryant Ranch PrepackANDACurrent
71930-017OndansetronOndansetronEywa Pharma Inc.ANDACurrent
71930-017OndansetronOndansetronEywa Pharma Inc.ANDACurrent
71930-017OndansetronOndansetronEywa Pharma Inc.ANDACurrent
71930-018OndansetronOndansetronEywa Pharma Inc.ANDACurrent
71930-018OndansetronOndansetronEywa Pharma Inc.ANDACurrent
71930-018OndansetronOndansetronEywa Pharma Inc.ANDACurrent
75921-459OndansetronOndansetronLife Line Home Care Services, Inc.ANDACurrent
80175-0017OndansetronOndansetronCentral PackagingANDACurrent
80175-0017OndansetronOndansetronCentral PackagingANDACurrent