FDA.reportPublic FDA data

Application 210817

Type
ANDA
Sponsor
MAYNE PHARMA 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
51862-542butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeineMayne PharmaANDACurrent
51862-542butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeineMayne PharmaANDACurrent