FDA.reportPublic FDA data

Application 207118

Type
ANDA
Sponsor
NUVO PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUTALBITAL, ACETAMINOPHEN AND CAFFEINEACETAMINOPHEN; BUTALBITAL; CAFFEINECAPSULE;ORAL300MG;50MG;40MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10135-628Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineMarlex Pharmaceuticals IncANDACurrent
11534-187BUTALBITAL, ACETAMINOPHEN AND CAFFEINEbutalbital, acetaminophen and caffeineSUNRISE PHARMACEUTICAL, INCANDACurrent
11534-187BUTALBITAL, ACETAMINOPHEN AND CAFFEINEbutalbital, acetaminophen and caffeineSUNRISE PHARMACEUTICAL, INCANDACurrent
11534-187BUTALBITAL, ACETAMINOPHEN AND CAFFEINEbutalbital, acetaminophen and caffeineSUNRISE PHARMACEUTICAL, INCANDACurrent
51407-200BUTALBITAL, ACETAMINOPHEN AND CAFFEINEbutalbital, acetaminophen and caffeineGolden State Medical Supply Inc.ANDACurrent
51407-200BUTALBITAL, ACETAMINOPHEN AND CAFFEINEbutalbital, acetaminophen and caffeineGolden State Medical SupplyANDACurrent
63629-2372BUTALBITAL, ACETAMINOPHEN AND CAFFEINEbutalbital, acetaminophen and caffeineBryant Ranch PrepackANDACurrent
63629-2372BUTALBITAL, ACETAMINOPHEN AND CAFFEINEbutalbital, acetaminophen and caffeineBryant Ranch PrepackANDACurrent
63629-2372BUTALBITAL, ACETAMINOPHEN AND CAFFEINEbutalbital, acetaminophen and caffeineBryant Ranch PrepackANDACurrent