FDA.reportPublic FDA data

Application 017534

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
003FIORINALASPIRIN; BUTALBITAL; CAFFEINETABLET;ORAL325MG;50MG;40MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
005FIORINALASPIRIN; BUTALBITAL; CAFFEINECAPSULE;ORAL325MG;50MG;40MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0023-6146FiorinalButalbital, Aspirin, and CaffeineAllergan, Inc.NDACurrent
0023-6146FiorinalButalbital, Aspirin, and CaffeineAllergan, Inc.NDACurrent
0023-6146FiorinalButalbital, Aspirin, and CaffeineAllergan, Inc.NDACurrent
0591-3219Butalbital, Aspirin, and Caffeinebutalbital, aspirin, and caffeineActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-3219Butalbital, Aspirin, and Caffeinebutalbital, aspirin, and caffeineActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-3219Butalbital, Aspirin, and Caffeinebutalbital, aspirin, and caffeineActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-3219Butalbital, Aspirin, and Caffeinebutalbital, aspirin, and caffeineActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-3219Butalbital, Aspirin, and Caffeinebutalbital, aspirin, and caffeineActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
33261-922Butalbital, Aspirin, and Caffeinebutalbital, aspirin, and caffeineAidarex Pharmaceuticals LLCNDA AUTHORIZED GENERICCurrent
52544-955FiorinalButalbital, Aspirin, and CaffeineActavis Pharma, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67230SUPPL2021-04-29
67223SUPPL2021-04-29