Application 077433

Type
ANDA
Sponsor
AREVA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PAMIDRONATE DISODIUMPAMIDRONATE DISODIUMINJECTABLE;INJECTION30MG/VIALNoNo
002PAMIDRONATE DISODIUMPAMIDRONATE DISODIUMINJECTABLE;INJECTION60MG/VIALNoNo
003PAMIDRONATE DISODIUMPAMIDRONATE DISODIUMINJECTABLE;INJECTION90MG/VIALNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59923-601Pamidronate DisodiumPamidronate DisodiumAreva Pharmaceuticals Inc.ANDACurrent
59923-601Pamidronate DisodiumPamidronate DisodiumAreva Pharmaceuticals Inc.ANDACurrent
59923-601Pamidronate DisodiumPamidronate DisodiumAreva Pharmaceuticals Inc.ANDACurrent
59923-602Pamidronate DisodiumPamidronate DisodiumAreva Pharmaceuticals Inc.ANDACurrent
59923-602Pamidronate DisodiumPamidronate DisodiumAreva Pharmaceuticals Inc.ANDACurrent
59923-602Pamidronate DisodiumPamidronate DisodiumAreva Pharmaceuticals Inc.ANDACurrent
59923-603Pamidronate DisodiumPamidronate DisodiumAreva Pharmaceuticals Inc.ANDACurrent
59923-603Pamidronate DisodiumPamidronate DisodiumAreva Pharmaceuticals Inc.ANDACurrent
59923-603Pamidronate DisodiumPamidronate DisodiumAreva Pharmaceuticals Inc.ANDACurrent