FDA.report

Application 077557

Type
ANDA
Sponsor
SUN PHARM INDS

Related Records

Application Products

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

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
42254-077ONDANSETRONONDANSETRONRebel Distributors CorpANDACurrent
42254-097ONDANSETRONONDANSETRONRebel Distributors CorpANDACurrent
50090-2103ondansetronondansetronA-S Medication SolutionsANDACurrent
50090-2104ondansetronondansetronA-S Medication SolutionsANDACurrent
50090-5346ondansetronondansetronA-S Medication SolutionsANDACurrent
50090-5346ondansetronondansetronA-S Medication SolutionsANDACurrent
50090-5346ondansetronondansetronA-S Medication SolutionsANDACurrent
50436-0133ondansetronondansetronUnit Dose ServicesANDACurrent
53217-360ondansetronondansetronAidarex Pharmaceuticals LLCANDACurrent
55154-4567ondansetronondansetronCardinal HealthANDACurrent
55154-4567ondansetronondansetronCardinal HealthANDACurrent
55154-4567ondansetronondansetronCardinal Health 107, LLCANDACurrent
60760-313ondansetronondansetronSt. Mary's Medical Park PharmacyANDACurrent
62756-240ondansetronondansetronSun Pharmaceutical Industries, Inc.ANDACurrent
62756-240ondansetronondansetronSun Pharmaceutical Industries, Inc.ANDACurrent
62756-240ondansetronondansetronSun Pharmaceutical Industries, Inc.ANDACurrent
62756-356ondansetronondansetronSun Pharmaceutical Industries, Inc.ANDACurrent
62756-356ondansetronondansetronSun Pharmaceutical Industries, Inc.ANDACurrent
62756-356ondansetronondansetronSun Pharmaceutical Industries, Inc.ANDACurrent
63187-670ONDANSETRONONDANSETRONProficient Rx LPANDACurrent
63187-670ONDANSETRONONDANSETRONProficient Rx LPANDACurrent
63187-693ONDANSETRONONDANSETRONProficient Rx LPANDACurrent
63187-693ONDANSETRONONDANSETRONProficient Rx LPANDACurrent
63187-693ONDANSETRONONDANSETRONProficient Rx LPANDACurrent
63187-693ONDANSETRONONDANSETRONProficient Rx LPANDACurrent
63629-4306ONDANSETRONondansetronBryant Ranch PrepackANDACurrent
63629-4306ONDANSETRONondansetronBryant Ranch PrepackANDACurrent
68071-1968ONDANSETRONONDANSETRONNuCare Pharmaceutical, Inc.ANDACurrent
68071-1977ONDANSETRONONDANSETRONNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2284ondansetronondansetronNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2284ondansetronondansetronNuCare Pharmaceuticals,Inc.ANDACurrent
68071-2652ONDANSETRONONDANSETRONNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5230ondansetronondansetronNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5230ondansetronondansetronNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7705ondansetronondansetronPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7705ondansetronondansetronPreferred Pharmaceuticals, Inc.ANDACurrent
70518-0042ONDANSETRONONDANSETRONREMEDYREPACK INC.ANDACurrent
70518-0042ONDANSETRONONDANSETRONREMEDYREPACK INC.ANDACurrent
70518-0235ONDANSETRONONDANSETRONREMEDYREPACK INC.ANDACurrent
70518-0235ONDANSETRONONDANSETRONREMEDYREPACK INC.ANDACurrent
70934-448ONDANSETRONONDANSETRONDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0831ondansetronondansetronBryant Ranch PrepackANDACurrent