FDA.report

Application 090469

Type
ANDA
Sponsor
AUROBINDO PHARMA

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001ONDANSETRONONDANSETRONTABLET, ORALLY DISINTEGRATING;ORAL4MGNoNo
002ONDANSETRONONDANSETRONTABLET, ORALLY DISINTEGRATING;ORAL8MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-200OndansetronOndansetronNorthStar Rx LLCANDACurrent
16714-200OndansetronOndansetronNorthStar Rx LLCANDACurrent
16714-200OndansetronOndansetronNorthStar Rx LLCANDACurrent
16714-200OndansetronOndansetronNorthStar Rx LLCANDACurrent
16714-200OndansetronOndansetronNorthStar Rx LLCANDACurrent
16714-201OndansetronOndansetronNorthStar Rx LLCANDACurrent
16714-201OndansetronOndansetronNorthStar Rx LLCANDACurrent
16714-201OndansetronOndansetronNorthStar Rx LLCANDACurrent
16714-201OndansetronOndansetronNorthStar Rx LLCANDACurrent
16714-201OndansetronOndansetronNorthStar Rx LLCANDACurrent
33358-498OndansetronOndansetronRxChange Co.ANDACurrent
33358-512OndansetronOndansetronRxChange Co.ANDACurrent
43063-857OndansetronOndansetronPD-Rx Pharmaceuticals, InANDACurrent
43063-857OndansetronOndansetronPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-857OndansetronOndansetronPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-857OndansetronOndansetronPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-857OndansetronOndansetronPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-857OndansetronOndansetronPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-857OndansetronOndansetronPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-857OndansetronOndansetronPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-857OndansetronOndansetronPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-857OndansetronOndansetronPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-857OndansetronOndansetronPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-870OndansetronOndansetronPD-Rx Pharmaceuticals, InANDACurrent
43063-870OndansetronOndansetronPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-870OndansetronOndansetronPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-870OndansetronOndansetronPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-870OndansetronOndansetronPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-870OndansetronOndansetronPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-870OndansetronOndansetronPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-870OndansetronOndansetronPD-Rx Pharmaceuticals, Inc.ANDACurrent
45865-105OndansetronOndansetronMedsource PharmaceuticalsANDACurrent
45865-563OndansetronOndansetronMedsource PharmaceuticalsANDACurrent
45865-563OndansetronOndansetronMedsource PharmaceuticalsANDACurrent
50090-1128OndansetronOndansetronA-S Medication SolutionsANDACurrent
50090-1128OndansetronOndansetronA-S Medication SolutionsANDACurrent
50090-1128OndansetronOndansetronA-S Medication SolutionsANDACurrent
50090-1128OndansetronOndansetronA-S Medication SolutionsANDACurrent
50090-1128OndansetronOndansetronA-S Medication SolutionsANDACurrent
50090-1200OndansetronOndansetronA-S Medication SolutionsANDACurrent
50090-1200OndansetronOndansetronA-S Medication SolutionsANDACurrent
50090-1200OndansetronOndansetronA-S Medication SolutionsANDACurrent
50090-1200OndansetronOndansetronA-S Medication SolutionsANDACurrent
50090-1200OndansetronOndansetronA-S Medication SolutionsANDACurrent
50090-1200OndansetronOndansetronA-S Medication SolutionsANDACurrent
50090-1200OndansetronOndansetronA-S Medication SolutionsANDACurrent
50090-1200OndansetronOndansetronA-S Medication SolutionsANDACurrent
50090-1201OndansetronOndansetronA-S Medication SolutionsANDACurrent
50090-1201OndansetronOndansetronA-S Medication SolutionsANDACurrent
50090-1201OndansetronOndansetronA-S Medication SolutionsANDACurrent
50090-4632OndansetronOndansetronA-S Medication SolutionsANDACurrent
50090-4632OndansetronOndansetronA-S Medication SolutionsANDACurrent
50436-0390OndansetronOndansetronUnit Dose ServicesANDACurrent
51655-809OndansetronOndansetronNorthwind PharmaceuticalsANDACurrent
51655-913OndansetronOndansetronNorthwind PharmaceuticalsANDACurrent
51662-1246ONDANSETRONONDANSETRONHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1246ONDANSETRONONDANSETRONHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1246ONDANSETRONONDANSETRONHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1246ONDANSETRONONDANSETRONHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1514ONDANSETRONONDANSETRONHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1514ONDANSETRONONDANSETRONHF Acquisition Co LLC, DBA HealthFirstANDACurrent
51662-1514ONDANSETRONONDANSETRONHF Acquisition Co LLC, DBA HealthFirstANDACurrent
52959-425ONDANSETRONONDANSETRONH. J. Harkins Company Inc.ANDACurrent
53002-0582OndansetronOndansetronRPK Pharmaceuticals, Inc.ANDACurrent
53002-0590OndansetronOndansetronRPK Pharmaceuticals, Inc.ANDACurrent
53002-0590OndansetronOndansetronRPK Pharmaceuticals, Inc.ANDACurrent
53002-0591OndansetronOndansetronRPK Pharmaceuticals, Inc.ANDACurrent
53217-382OndansetronOndansetronAidarex Pharmaceuticals LLCANDACurrent
55700-672OndansetronOndansetronLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-672OndansetronOndansetronLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-672OndansetronOndansetronLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-952OndansetronOndansetronQuality Care Products, LLCANDACurrent
55700-952OndansetronOndansetronQuality Care Products, LLCANDACurrent
57237-077OndansetronOndansetronRising Health, LLCANDACurrent
57237-077OndansetronOndansetronRising Health, LLCANDACurrent
57237-077OndansetronOndansetronRising Health, LLCANDACurrent
57237-077OndansetronOndansetronRising Health, LLCANDACurrent
57237-077OndansetronOndansetronRising Health, LLCANDACurrent
57237-078OndansetronOndansetronRising Health, LLCANDACurrent
57237-078OndansetronOndansetronRising Health, LLCANDACurrent