FDA.report

Application 078152

Type
ANDA
Sponsor
GLENMARK GENERICS

Related Records

Application Products

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

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
33261-747OndansetronOndansetronAidarex Pharmaceuticals LLCANDACurrent
33261-761OndansetronOndansetronAidarex Pharmaceuticals LLCANDACurrent
42254-212OndansetronOndansetronRebel Distributors CorpANDACurrent
42254-213OndansetronOndansetronRebel Distributors CorpANDACurrent
43063-273OndansetronOndansetronPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-273OndansetronOndansetronPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-273OndansetronOndansetronPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-273OndansetronOndansetronPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-273OndansetronOndansetronPD-Rx Pharmaceuticals, Inc.ANDACurrent
45865-598OndansetronOndansetronMedsource PharmaceuticalsANDACurrent
45865-598OndansetronOndansetronMedsource PharmaceuticalsANDACurrent
50090-1658OndansetronOndansetronA-S Medication SolutionsANDACurrent
50090-1658OndansetronOndansetronA-S Medication SolutionsANDACurrent
50090-1658OndansetronOndansetronA-S Medication SolutionsANDACurrent
50090-1659OndansetronOndansetronA-S Medication SolutionsANDACurrent
50090-1659OndansetronOndansetronA-S Medication SolutionsANDACurrent
50090-1660OndansetronOndansetronA-S Medication SolutionsANDACurrent
50090-1660OndansetronOndansetronA-S Medication SolutionsANDACurrent
50090-1660OndansetronOndansetronA-S Medication SolutionsANDACurrent
50436-0134OndansetronOndansetronUnit Dose ServicesANDACurrent
53002-0580OndansetronOndansetronRPK Pharmaceuticals, Inc.ANDACurrent
53002-0580OndansetronOndansetronRPK Pharmaceuticals, Inc.ANDACurrent
55045-3848OndansetronOndansetronDispensing Solutions, Inc.ANDACurrent
55154-3680OndansetronOndansetronCardinal HealthANDACurrent
55154-3680OndansetronOndansetronCardinal Health 107, LLCANDACurrent
55154-3680OndansetronOndansetronCardinal HealthANDACurrent
55154-3680OndansetronOndansetronCardinal HealthANDACurrent
55154-3683OndansetronOndansetronCardinal HealthANDACurrent
60760-654OndansetronOndansetronST. MARY'S MEDICAL PARK PHARMACYANDACurrent
63187-199OndansetronOndansetronProficient Rx LPANDACurrent
63187-199OndansetronOndansetronProficient Rx LPANDACurrent
63187-199OndansetronOndansetronProficient Rx LPANDACurrent
63187-256OndansetronOndansetronProficient Rx LPANDACurrent
63187-256OndansetronOndansetronProficient Rx LPANDACurrent
63187-256OndansetronOndansetronProficient Rx LPANDACurrent
63629-4014OndansetronOndansetronBryant Ranch PrepackANDACurrent
63629-4014OndansetronOndansetronBryant Ranch PrepackANDACurrent
63629-4014OndansetronOndansetronBryant Ranch PrepackANDACurrent
68001-246OndansetronOndansetronBluePoint LaboratoriesANDACurrent
68001-246OndansetronOndansetronBluePoint LaboratoriesANDACurrent
68001-246OndansetronOndansetronBluePoint LaboratoriesANDACurrent
68001-246OndansetronOndansetronBluePoint LaboratoriesANDACurrent
68001-247OndansetronOndansetronBluePoint LaboratoriesANDACurrent
68001-247OndansetronOndansetronBluePoint LaboratoriesANDACurrent
68001-247OndansetronOndansetronBluePoint LaboratoriesANDACurrent
68001-247OndansetronOndansetronBluePoint LaboratoriesANDACurrent
68071-1547OndansetronOndansetronNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2718OndansetronOndansetronNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2901OndansetronOndansetronNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3268OndansetronOndansetronNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3268OndansetronOndansetronNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3268OndansetronOndansetronNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4115OndansetronOndansetronNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4115OndansetronOndansetronNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4566OndansetronOndansetronNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4566OndansetronOndansetronNuCare Pharmaceuticals,Inc.ANDACurrent
68258-7068OndansetronOndansetronDispensing Solutions, Inc.ANDACurrent
68462-157OndansetronOndansetronGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-157OndansetronOndansetronGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-157OndansetronOndansetronGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-157OndansetronOndansetronGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-158OndansetronOndansetronGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-158OndansetronOndansetronGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-158OndansetronOndansetronGlenmark Pharmaceuticals Inc., USAANDACurrent
68462-158OndansetronOndansetronGlenmark Pharmaceuticals Inc., USAANDACurrent
68788-9329OndansetronOndansetronPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9770OndansetronOndansetronPreferred Pharmaceuticals, Inc.ANDACurrent
70518-3512OndansetronOndansetronREMEDYREPACK INC.ANDACurrent
70518-3512OndansetronOndansetronREMEDYREPACK INC.ANDACurrent
80425-0222OndansetronOndansetronAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0227OndansetronOndansetronAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent