FDA.reportPublic FDA data

Application 204371

Type
ANDA
Sponsor
MOUNTAIN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GRISEOFULVIN, ULTRAMICROSIZEGRISEOFULVIN, ULTRAMICROSIZETABLET;ORAL125MGNoNo
002GRISEOFULVIN, ULTRAMICROSIZEGRISEOFULVIN, ULTRAMICROSIZETABLET;ORAL250MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-1724Ultramicrosize GriseofulvinUltramicrosize Griseofulvin TabletsImpax GenericsANDACurrent
0115-1724Ultramicrosize GriseofulvinUltramicrosize Griseofulvin TabletsAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1724Ultramicrosize GriseofulvinUltramicrosize Griseofulvin TabletsAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1725Ultramicrosize GriseofulvinUltramicrosize Griseofulvin TabletsImpax GenericsANDACurrent
0115-1725Ultramicrosize GriseofulvinUltramicrosize Griseofulvin TabletsAmneal Pharmaceuticals of New York LLCANDACurrent
0115-1725Ultramicrosize GriseofulvinUltramicrosize Griseofulvin TabletsAmneal Pharmaceuticals of New York LLCANDACurrent
64720-295Ultramicrosize GriseofulvinUltramicrosize Griseofulvin TabletsCorePharma, LLCANDACurrent
64720-296Ultramicrosize GriseofulvinUltramicrosize Griseofulvin TabletsCorePharma, LLCANDACurrent