FDA.reportPublic FDA data

Application 212083

Type
ANDA
Sponsor
LANNETT CO INC

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
0527-4094butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeineLannett Company, Inc.ANDACurrent
0527-4094butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeineLannett Company, Inc.ANDACurrent
63629-2087butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeineBryant Ranch PrepackANDACurrent
63629-2087butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeineBryant Ranch PrepackANDACurrent
63629-2087butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeineBryant Ranch PrepackANDACurrent