FDA.reportPublic FDA data

Application 040261

Type
ANDA
Sponsor
HIKMA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUTALBITAL, ACETAMINOPHEN AND CAFFEINEACETAMINOPHEN; BUTALBITAL; CAFFEINECAPSULE;ORAL500MG;50MG;40MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-0170Butalbital, Acetaminophen, and CaffeineButalbital, Acetaminophen, and CaffeineWest-Ward Pharmaceutical CorpANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
53877ORIG2018-05-01
42603ORIG2002-09-26
17757ORIG1998-10-28
7594ORIG1998-10-28