FDA.reportPublic FDA data

Application 089718

Type
ANDA
Sponsor
HIKMA PHARMS

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
0143-1787Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineWest-Ward Pharmaceuticals CorpANDACurrent
0143-1787Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineHikma Pharmaceuticals USA Inc.ANDACurrent
0904-6538Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineMajor PharmaceuticalsANDACurrent
0904-6538Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineMajor PharmaceuticalsANDACurrent
17856-1787Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineAtlantic Biologicals CorpsANDACurrent
21695-209Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineRebel Distributors CorpANDACurrent
43063-369Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeinePD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-2105Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineA-S Medication SolutionsANDACurrent
50090-2105Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineA-S Medication SolutionsANDACurrent
50268-139Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineAvPAKANDACurrent
55154-7988Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineCardinal HealthANDACurrent
68788-9025Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeinePreferred Pharmaceuticals, Inc.ANDACurrent