Application 060569

Type
ANDA
Sponsor
CHARTWELL RX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FULVICIN-U/FGRISEOFULVIN, MICROCRYSTALLINETABLET;ORAL500MGNoNo
002FULVICIN-U/FGRISEOFULVIN, MICROCRYSTALLINETABLET;ORAL250MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62135-496Griseofulvin MICROSIZEgriseofulvinChartwell RX, LLC.ANDACurrent
62135-496Griseofulvin MICROSIZEgriseofulvinChartwell RX, LLC.ANDACurrent