FDA.reportPublic FDA data

Application 091592

Type
ANDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GRISEOFULVINGRISEOFULVIN, MICROSIZETABLET;ORAL250MGNoNo
002GRISEOFULVINGRISEOFULVIN, MICROSIZETABLET;ORAL500MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-5514GriseofulvinGriseofulvinSandoz IncANDACurrent
0781-5514GriseofulvinGriseofulvinSandoz IncANDACurrent
0781-5515GriseofulvinGriseofulvinSandoz IncANDACurrent
0781-5515GriseofulvinGriseofulvinSandoz IncANDACurrent