FDA.reportPublic FDA data

Application 212082

Type
ANDA
Sponsor
LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUTALBITAL, ACETAMINOPHEN AND CAFFEINEACETAMINOPHEN; BUTALBITAL; CAFFEINECAPSULE;ORAL300MG;50MG;40MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0527-4095Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine CapsulesLannett Company, Inc.ANDACurrent
0527-4095Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and Caffeine CapsulesLannett Company, Inc.ANDACurrent