FDA.reportPublic FDA data

Application 089175

Type
ANDA
Sponsor
MIKART

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
46672-053butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeineMikart, LLCANDACurrent
46672-053butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeineMikart, LLCANDACurrent
50436-4856butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeineUnit Dose ServicesANDACurrent
51655-590Butalbital Acetaminophen and CaffeineButalbital Acetaminophen and CaffeineNorthwind PharmaceuticalsANDACurrent
51862-540butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeineMayne PharmaANDACurrent
51862-540butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeineMayne PharmaANDACurrent
51862-540butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeineMayne PharmaANDACurrent
51862-540butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeineMayne PharmaANDACurrent
60429-589butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeineGolden State Medical Supply, IncANDACurrent
60429-589butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeineGolden State Medical Supply, Inc.ANDACurrent
60429-589butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeineGolden State Medical SupplyANDACurrent
60429-589butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeineGolden State Medical SupplyANDACurrent
61919-022BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEDIRECT RXANDACurrent
61919-022BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEDIRECT RXANDACurrent
63187-520butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeineProficient Rx LPANDACurrent
63187-520butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeineProficient Rx LPANDACurrent
66267-039butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeineNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4657butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4657butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4657butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeineNuCare Pharmaceuticals,Inc.ANDACurrent
68308-220Esgicbutalbital, acetaminophen and caffeineMayne Pharma Inc.ANDACurrent
68308-220Esgicbutalbital, acetaminophen and caffeineMayne Pharma Inc.ANDACurrent
68308-220Esgicbutalbital, acetaminophen and caffeineMayne Pharma Inc.ANDACurrent
68788-9711butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeinePreferred Pharmaceuticals, Inc.ANDACurrent
71335-0347butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeineBryant Ranch PrepackANDACurrent
71335-0347butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeineBryant Ranch PrepackANDACurrent
71335-0347butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeineBryant Ranch PrepackANDACurrent
71610-042butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeineAphena Pharma Solutions - Tennessee, LLCANDACurrent