FDA.reportPublic FDA data

Application 200243

Type
ANDA
Sponsor
LANNETT CO 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
0527-1695Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineLannett Company, Inc.ANDACurrent
0527-1695Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineLannett Company, Inc.ANDACurrent
0527-1695Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineLannett Company, Inc.ANDACurrent
0527-1695Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineLannett Company, Inc.ANDACurrent
0904-6938Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineMajor PharmaceuticalsANDACurrent
0904-6938Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineMajor PharmaceuticalsANDACurrent
33358-059Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineRxChange Co.ANDACurrent
45865-352Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineMedsource PharmaceuticalsANDACurrent
45865-352Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineMedsource PharmaceuticalsANDACurrent
50090-2564Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineA-S Medication SolutionsANDACurrent
50436-1695Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineUnit Dose ServicesANDACurrent
53002-6030Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineRPK Pharmaceuticals, Inc.ANDACurrent
53002-6030Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineRPK Pharmaceuticals, Inc.ANDACurrent
55700-662Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-662Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineLake Erie Medical DBA QuaANDACurrent
55700-662Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineLake Erie Medical DBA Quality Care Products LLCANDACurrent
63187-933Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineProficient Rx LPANDACurrent
63187-933Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineProficient Rx LPANDACurrent
63187-933Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineProficient Rx LPANDACurrent
63187-933Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineProficient Rx LPANDACurrent
63629-8392Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineBryant Ranch PrepackANDACurrent
68071-3120Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3249Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3249Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineNuCare Pharmaceuticals, Inc.ANDACurrent
68788-6939Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeinePreferred Pharmaceuticals Inc.ANDACurrent
70518-1134Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineREMEDYREPACK INC.ANDACurrent
70518-1134Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineREMEDYREPACK INC.ANDACurrent
70518-1134Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineREMEDYREPACK INC.ANDACurrent
70518-1134Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineREMEDYREPACK INC.ANDACurrent
70518-1134Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineREMEDYREPACK INC.ANDACurrent
70518-1134Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineREMEDYREPACK INC.ANDACurrent
71335-0365Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineBryant Ranch PrepackANDACurrent
71335-0365Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineBryant Ranch PrepackANDACurrent
71335-0365Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineBryant Ranch PrepackANDACurrent