FDA.reportPublic FDA data

Application 065385

Type
ANDA
Sponsor
LYNE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ERYTHROMYCIN AND BENZOYL PEROXIDEBENZOYL PEROXIDE; ERYTHROMYCINGEL;TOPICAL5%;3%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
64980-328Erythromycin and Benzoyl PeroxideErythromycin and Benzoyl PeroxideRising Pharmaceuticals, Inc.ANDACurrent
64980-328Erythromycin and Benzoyl PeroxideErythromycin and Benzoyl PeroxideRising Pharmaceuticals, Inc.ANDACurrent
64980-328Erythromycin and Benzoyl PeroxideErythromycin and Benzoyl PeroxideRising Pharmaceuticals, Inc.ANDACurrent