FDA.reportPublic FDA data

Application 204733

Type
ANDA
Sponsor
AUROLIFE PHARMA LLC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13107-075Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineAurolife Pharma, LLCANDACurrent
13107-075Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineAurolife Pharma, LLCANDACurrent