FDA.reportPublic FDA data

Application 040864

Type
ANDA
Sponsor
NOVAST LABS

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
51407-556Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineGolden State Medical Supply, Inc.ANDACurrent
70010-149Butalbital, Acetaminophen and CaffeineButalbital, Acetaminophen and CaffeineGranules Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
53886ORIG2018-05-01