FDA.reportPublic FDA data

Application 213321

Type
ANDA
Sponsor
GRANULES PHARMS

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
70010-044Butalbita,Acetaminophen and CaffeineButalbita,Acetaminophen and CaffeineGranules Pharmaceuticals Inc.ANDACurrent
70010-044Butalbita,Acetaminophen and CaffeineButalbita,Acetaminophen and CaffeineGranules Pharmaceuticals Inc.ANDACurrent
70010-044Butalbita,Acetaminophen and CaffeineButalbita,Acetaminophen and CaffeineGranules Pharmaceuticals Inc.ANDACurrent
80425-0215Butalbital/Acetaminophen/CaffeineButalbital/Acetaminophen/CaffeineAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent