FDA.reportPublic FDA data

Application 040387

Type
ANDA
Sponsor
MIKART

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUTALBITAL, ACETAMINOPHEN AND CAFFEINEACETAMINOPHEN; BUTALBITAL; CAFFEINESOLUTION;ORAL325MG/15ML;50MG/15ML;40MG/15MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
46672-633butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeineMikart, LLCANDACurrent
46672-633butalbital, acetaminophen and caffeinebutalbital, acetaminophen and caffeineMikart, Inc.ANDACurrent
46672-633Butalbital, Acetaminophen and Caffeinebutalbital, acetaminophen and caffeineMikart, LLCANDACurrent
46672-633Butalbital, Acetaminophen and Caffeinebutalbital, acetaminophen and caffeineMikart, LLCANDACurrent
58809-359Vanatolbutalbital, acetaminophen and caffeineGM PharmaceuticalsANDACurrent
58809-359Vanatolbutalbital, acetaminophen and caffeineGM PharmaceuticalsANDACurrent
58809-820Vanatolbutalbital, acetaminophen and caffeineGM PharmaceuticalsANDACurrent
58809-820Vanatolbutalbital, acetaminophen and caffeineGM PharmaceuticalsANDACurrent
70154-111Vtol LQbutalbital, acetaminophen and caffeineMonarch PCM, LLCANDACurrent
70154-111Vtol LQbutalbital, acetaminophen and caffeineMonarch PCM, LLCANDACurrent
70154-111Vtol LQbutalbital, acetaminophen and caffeineMonarch PCM, LLCANDACurrent
70154-111Vtol LQbutalbital, acetaminophen and caffeineMonarch PCM, LLCANDACurrent