FDA.reportPublic FDA data

Application 078050

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ONDANSETRONONDANSETRONTABLET, ORALLY DISINTEGRATING;ORAL4MGNoNo
002ONDANSETRONONDANSETRONTABLET, ORALLY DISINTEGRATING;ORAL8MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-5238OndansetronOndansetronSandoz IncANDACurrent
0781-5238OndansetronOndansetronSandoz IncANDACurrent
0781-5238OndansetronOndansetronSandoz IncANDACurrent
0781-5239OndansetronOndansetronSandoz IncANDACurrent
0781-5239OndansetronOndansetronSandoz IncANDACurrent
0781-5239OndansetronOndansetronSandoz IncANDACurrent
21695-380OndansetronOndansetronRebel Distributors Corp.ANDACurrent
35356-755OndansetronOndansetronLake Erie Medical DBA Quality Care Products LLCANDACurrent
43063-560OndansetronOndansetronPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-560OndansetronOndansetronPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-592OndansetronOndansetronPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-592OndansetronOndansetronPD-Rx Pharmaceuticals, Inc.ANDACurrent
55154-5431OndansetronOndansetronCardinal HealthANDACurrent
61919-218ONDANSETRONONDANSETRONDIRECT RXANDACurrent
63187-002OndansetronOndansetronProficient Rx LPANDACurrent
63187-002OndansetronOndansetronProficient Rx LPANDACurrent
63187-483OndansetronOndansetronProficient Rx LPANDACurrent
63187-483OndansetronOndansetronProficient Rx LPANDACurrent
63629-7513OndansetronOndansetronBryant Ranch PrepackANDACurrent
68071-1658OndansetronOndansetronNuCare Pharmaceuticals,Inc.ANDACurrent
70518-0291OndansetronOndansetronREMEDYREPACK INC.ANDACurrent
70518-0291OndansetronOndansetronREMEDYREPACK INC.ANDACurrent
70518-0828OndansetronOndansetronREMEDYREPACK INC.ANDACurrent
70518-0828OndansetronOndansetronREMEDYREPACK INC.ANDACurrent
71335-0491OndansetronOndansetronBryant Ranch PrepackANDACurrent
71335-0549OndansetronOndansetronBryant Ranch PrepackANDACurrent
71335-0549OndansetronOndansetronBryant Ranch PrepackANDACurrent