FDA.reportPublic FDA data

Application 088616

Type
ANDA
Sponsor
ACTAVIS LABS UT INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUTALBITAL, ACETAMINOPHEN AND CAFFEINEACETAMINOPHEN; BUTALBITAL; CAFFEINETABLET;ORAL325MG;50MG;40MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-3369Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineActavis Pharma, Inc.ANDACurrent
0591-3369Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineActavis Pharma, Inc.ANDACurrent
49999-151Butalbital Acetaminophen and CaffeineButalbital Acetaminophen and CaffeineLake Erie Medical DBA Quality Care Products LLCANDACurrent
50090-0371Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineA-S Medication SolutionsANDACurrent
50436-3369Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineUnit Dose ServicesANDACurrent
55154-3416FioricetButalbital, Acetaminophen, and CaffeineCardinal HealthANDACurrent
68788-9287Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeinePreferred Pharmaceuticals Inc.ANDACurrent