FDA.reportPublic FDA data

Application 211543

Type
ANDA
Sponsor
NESHER PHARMS

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
70710-1378Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1378Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineZydus Pharmaceuticals (USA) Inc.ANDACurrent