FDA.reportPublic FDA data

Application 087003

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ROXICETACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-0551Oxycodone and AcetaminophenOxycodone and AcetaminophenWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0551Oxycodone and AcetaminophenOxycodone and AcetaminophenWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0551Oxycodone and AcetaminophenOxycodone and AcetaminophenWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0551Oxycodone and AcetaminophenOxycodone and AcetaminophenWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-0551Oxycodone and AcetaminophenOxycodone and AcetaminophenWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-4650RoxicetOxycodone and AcetaminophenWest-Ward Pharmaceuticals CorpANDACurrent
0054-8650RoxicetOxycodone and AcetaminophenWest-Ward Pharmaceuticals CorpANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76206ORIG 2023-11-03