FDA.reportPublic FDA data

Application 214088

Type
ANDA
Sponsor
HAVIX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUTALBITAL AND ACETAMINOPHENACETAMINOPHEN; BUTALBITALTABLET;ORAL25MG;325MGNoNo
002BUTALBITAL AND ACETAMINOPHENACETAMINOPHEN; BUTALBITALTABLET;ORAL50MG;325MGNoNo
003BUTALBITAL AND ACETAMINOPHENACETAMINOPHEN; BUTALBITALTABLET;ORAL50MG;300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
35573-455BUTALBITAL AND ACETAMINOPHENbutalbital and acetaminophenBurel Pharmaceuticals, LLCANDACurrent
35573-455BUTALBITAL AND ACETAMINOPHENbutalbital and acetaminophenBurel Pharmaceuticals, LLCANDACurrent
35573-456BUTALBITAL AND ACETAMINOPHENbutalbital and acetaminophenBurel Pharmaceuticals, LLCANDACurrent
35573-456BUTALBITAL AND ACETAMINOPHENbutalbital and acetaminophenBurel Pharmaceuticals, LLCANDACurrent