FDA.reportPublic FDA data

Application 086162

Type
ANDA
Sponsor
HIKMA INTL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002BUTALBITAL, ASPIRIN AND CAFFEINEASPIRIN; BUTALBITAL; CAFFEINETABLET;ORAL325MG;50MG;40MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-1785Butalbital, Aspirin and CaffeineButalbital, Aspirin and CaffeineWest-ward Pharmaceutical CorpANDACurrent
21695-354Butalbital, Aspirin and CaffeineButalbital, Aspirin and CaffeineRebel Distributors CorpANDACurrent
52959-370Butalbital, Aspirin and CaffeineButalbital, Aspirin and CaffeineH.J. Harkins CompanyANDACurrent
66336-619Butalbital, Aspirin and CaffeineButalbital, Aspirin and CaffeineDispensing Solutions, Inc.ANDACurrent