FDA.reportPublic FDA data

Application 203647

Type
ANDA
Sponsor
STRIDES PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUTALBITAL, ACETAMINOPHEN AND CAFFEINEACETAMINOPHEN; BUTALBITAL; CAFFEINETABLET;ORAL325MG;50MG;40MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42543-094Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineStrides Pharma Inc.ANDACurrent
42543-094Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineVensun Pharmaceuticals, Inc.ANDACurrent