FDA.reportPublic FDA data

Application 089007

Type
ANDA
Sponsor
MAYNE PHARMA INC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51862-179butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeineMayne PharmaANDACurrent
51862-179butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeineMayne PharmaANDACurrent
51862-179butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeineMayne PharmaANDACurrent
68308-219Esgicbutalbital, acetaminophen and caffeineMayne Pharma Inc.ANDACurrent
68308-219Esgicbutalbital, acetaminophen and caffeineMayne Pharma Inc.ANDACurrent
68308-219Esgicbutalbital, acetaminophen and caffeineMayne Pharma Inc.ANDACurrent
68308-554Zebutalbutalbital, acetaminophen and caffeineMayne Pharma Inc.ANDACurrent
68308-554Zebutalbutalbital, acetaminophen and caffeineMayne Pharma Inc.ANDACurrent
68308-554Zebutalbutalbital, acetaminophen and caffeineMayne Pharma Inc.ANDACurrent