Application 078602

Type
ANDA
Sponsor
SUN PHARM INDS LTD

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
63304-346ONDANSETRONONDANSETRONRnabaxy Pharmaceuticals Inc.ANDACurrent
63304-347ONDANSETRONONDANSETRONRnabaxy Pharmaceuticals Inc.ANDACurrent