FDA.reportPublic FDA data

Application 205120

Type
ANDA
Sponsor
CNTY LINE PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUTALBITAL AND ACETAMINOPHENACETAMINOPHEN; BUTALBITALTABLET;ORAL325MG;50MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47781-535Butalbital and AcetaminophenButalbital and AcetaminophenAlvogen, Inc.ANDACurrent
47781-535Butalbital and AcetaminophenButalbital and AcetaminophenAlvogen, Inc.ANDACurrent
47781-628Butalbital and AcetaminophenButalbital and AcetaminophenAlvogen, Inc.ANDACurrent
47781-628Butalbital and AcetaminophenButalbital and AcetaminophenAlvogen, Inc.ANDACurrent
47781-628Butalbital and AcetaminophenButalbital and AcetaminophenAlvogen, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
32633ORIG2015-11-03