FDA.reportPublic FDA data

Application 089987

Type
ANDA
Sponsor
MIKART

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUTAPAPACETAMINOPHEN; BUTALBITALTABLET;ORAL325MG;50MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0603-2540butalbital and acetaminophenbutalbital and acetaminophenPar PharmaceuticalANDACurrent
0603-2540butalbital and acetaminophenbutalbital and acetaminophenPar PharmaceuticalANDACurrent
0603-2540butalbital and acetaminophenbutalbital and acetaminophenPar PharmaceuticalANDACurrent
11584-0030Tenconbutalbital and acetaminophenInternational Ethical Labs, Inc.ANDACurrent
11584-0030Tenconbutalbital and acetaminophenInternational Ethical Labs, Inc.ANDACurrent
11584-0030Tenconbutalbital and acetaminophenInternational Ethical Labs, Inc.ANDACurrent
46672-099Butapapbutalbital and acetaminophenMikart, Inc.ANDACurrent
46672-099Butapapbutalbital and acetaminophenMikart, LLCANDACurrent
46672-099Butapapbutalbital and acetaminophenMikart, LLCANDACurrent