FDA.reportPublic FDA data

Application 040511

Type
ANDA
Sponsor
VINTAGE PHARMS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0603-2544Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen, and CaffeinePar PharmaceuticalANDACurrent
0603-2544Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen, and CaffeinePar Pharmaceutical, Inc.ANDACurrent
0603-2544Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen, and CaffeinePar PharmaceuticalANDACurrent
55154-7147BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINECardinal Health 107, LLCANDACurrent
55154-7147BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINECardinal HealthANDACurrent
55154-7147BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINECardinal HealthANDACurrent
55289-879Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen, and CaffeinePD-Rx Pharmaceuticals, Inc.ANDACurrent
55289-879Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen, and CaffeinePD-Rx Pharmaceuticals, Inc.ANDACurrent
60687-672Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen, and CaffeineAmerican Health PackagingANDACurrent
60687-672Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen, and CaffeineAmerican Health PackagingANDACurrent
63629-1774Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen, and CaffeineBryant Ranch PrepackANDACurrent
63629-2140Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen, and CaffeineBryant Ranch PrepackANDACurrent
63629-2140Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen, and CaffeineBryant Ranch PrepackANDACurrent
63629-2140Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen, and CaffeineBryant Ranch PrepackANDACurrent
63629-2140Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen, and CaffeineBryant Ranch PrepackANDACurrent
63629-2151Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen, and CaffeineBryant Ranch PrepackANDACurrent
63629-2151Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen, and CaffeineBryant Ranch PrepackANDACurrent
63629-2151Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen, and CaffeineBryant Ranch PrepackANDACurrent
63629-2151Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen, and CaffeineBryant Ranch PrepackANDACurrent
64380-157Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen, and CaffeineStrides Pharma Science LimitedANDACurrent
64380-157Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen, and CaffeineStrides Pharma Science LimitedANDACurrent
64380-157Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen, and CaffeineStrides Pharma Science LimitedANDACurrent
64380-157Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen, and CaffeineStrides Pharma Science LimitedANDACurrent
67296-0718Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineRedPharm Drug Inc.ANDACurrent
67544-394Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen, and CaffeineAphena Pharma Solutions - Tennessee, LLCANDACurrent
68084-396BUTALBITAL, ACETAMINOPHEN AND CAFFEINEBUTALBITAL, ACETAMINOPHEN AND CAFFEINEAmerican Health PackagingANDACurrent
68084-396Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineAmerican Health PackagingANDACurrent
68084-396Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineAmerican Health PackagingANDACurrent
68084-396Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineAmerican Health PackagingANDACurrent
68084-396Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineAmerican Health PackagingANDACurrent
68151-1313Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen, and CaffeineCarilion Materials ManagementANDACurrent
71335-1977Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen, and CaffeineBryant Ranch PrepackANDACurrent
71335-1977Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen, and CaffeineBryant Ranch PrepackANDACurrent