FDA.reportPublic FDA data

Application 214087

Type
ANDA
Sponsor
HAVIX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUTALBITAL, ACETAMINOPHEN AND CAFFEINEACETAMINOPHEN; BUTALBITAL; CAFFEINECAPSULE;ORAL300MG;50MG;40MGNoNo
002BUTALBITAL, ACETAMINOPHEN AND CAFFEINEACETAMINOPHEN; BUTALBITAL; CAFFEINECAPSULE;ORAL325MG;50MG;40MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13925-535BUTALBITAL, ACETAMINOPHEN AND CAFFEINEbutalbital, acetaminophen and caffeineSeton Pharmaceuticals LLCANDACurrent
13925-535BUTALBITAL, ACETAMINOPHEN AND CAFFEINEbutalbital, acetaminophen and caffeineSeton Pharmaceuticals LLCANDACurrent
13925-536BUTALBITAL, ACETAMINOPHEN AND CAFFEINEbutalbital, acetaminophen and caffeineSeton Pharmaceuticals LLCANDACurrent
13925-536BUTALBITAL, ACETAMINOPHEN AND CAFFEINEbutalbital, acetaminophen and caffeineSeton Pharmaceuticals LLCANDACurrent