FDA.reportPublic FDA data

Application 211106

Type
ANDA
Sponsor
ABHAI LLC

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
10702-253Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineKVK-Tech, Inc.ANDACurrent
10702-253Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineKVK-Tech, Inc.ANDACurrent
71335-9603Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineBryant Ranch PrepackANDACurrent