FDA.reportPublic FDA data

Application 090177

Type
ANDA
Sponsor
MAYNE PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;2.5MGNoNo
002OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;5MGNoNo
003OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;7.5MGNoNo
004OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL325MG;10MGNoNo
005OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL500MG;7.5MGNoNo
006OXYCODONE AND ACETAMINOPHENACETAMINOPHEN; OXYCODONE HYDROCHLORIDETABLET;ORAL650MG;10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67296-1401Oxycodone and AcetaminophenOxycodone and AcetaminophenRedPharm Drug, Inc.ANDACurrent
67296-1401Oxycodone and AcetaminophenOxycodone and AcetaminophenRedPharm Drug, Inc.ANDACurrent
68308-405Oxycodone and AcetaminophenOxycodone Hydrochloride and AcetaminophenMayne Pharma Inc.ANDACurrent
68308-405Oxycodone and AcetaminophenOxycodone Hydrochloride and AcetaminophenMayne Pharma Inc.ANDACurrent
68308-475Oxycodone and AcetaminophenOxycodone Hydrochloride and AcetaminophenMayne Pharma Inc.ANDACurrent
68308-475Oxycodone and AcetaminophenOxycodone Hydrochloride and AcetaminophenMayne Pharma Inc.ANDACurrent
68308-475Oxycodone and AcetaminophenOxycodone Hydrochloride and AcetaminophenMayne Pharma Inc.ANDACurrent
68308-475Oxycodone and AcetaminophenOxycodone Hydrochloride and AcetaminophenMayne Pharma Inc.ANDACurrent
68308-475Oxycodone and AcetaminophenOxycodone Hydrochloride and AcetaminophenMayne Pharma Inc.ANDACurrent
68308-480Oxycodone and AcetaminophenOxycodone Hydrochloride and AcetaminophenMayne Pharma Inc.ANDACurrent
68308-480Oxycodone and AcetaminophenOxycodone Hydrochloride and AcetaminophenMayne Pharma Inc.ANDACurrent
68308-480Oxycodone and AcetaminophenOxycodone Hydrochloride and AcetaminophenMayne Pharma Inc.ANDACurrent
68308-480Oxycodone and AcetaminophenOxycodone Hydrochloride and AcetaminophenMayne Pharma Inc.ANDACurrent
68308-480Oxycodone and AcetaminophenOxycodone Hydrochloride and AcetaminophenMayne Pharma Inc.ANDACurrent
68308-840Oxycodone and AcetaminophenOxycodone Hydrochloride and AcetaminophenMayne Pharma Inc.ANDACurrent
68308-841Oxycodone and AcetaminophenOxycodone Hydrochloride and AcetaminophenMayne Pharma Inc.ANDACurrent
68308-841Oxycodone and AcetaminophenOxycodone Hydrochloride and AcetaminophenMayne Pharma Inc.ANDACurrent
68308-842Oxycodone and AcetaminophenOxycodone Hydrochloride and AcetaminophenMayne Pharma Inc.ANDACurrent
68308-843Oxycodone and AcetaminophenOxycodone Hydrochloride and AcetaminophenMayne Pharma Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76108ORIG 2023-11-02