FDA.reportPublic FDA data

Application 202545

Type
ANDA
Sponsor
SIGMAPHARM LABS LLC

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
42794-013GriseofulvinGriseofulvinSigmapharm Laboratories, LLCANDACurrent
42794-013Ultramicrosize GriseofulvinUltramicrosize GriseofulvinSigmapharm Laboratories, LLCANDACurrent
42794-014GriseofulvinGriseofulvinSigmapharm Laboratories, LLCANDACurrent
42794-014Ultramicrosize GriseofulvinUltramicrosize GriseofulvinSigmapharm Laboratories, LLCANDACurrent
64980-184GriseofulvinGriseofulvinRising Pharmaceuticals, IncANDACurrent
64980-185GriseofulvinGriseofulvinRising Pharmaceuticals, IncANDACurrent