Application 091670

Type: ANDA
Sponsor: MAYNE PHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXYCODONE AND ASPIRIN	ASPIRIN; OXYCODONE HYDROCHLORIDE	TABLET;ORAL	325MG;4.8355MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68308-845	Oxycodone and Aspirin	Oxycodone Hydrochloride and Aspirin	Mayne Pharma Inc.	ANDA	Current
68308-845	Oxycodone and Aspirin	Oxycodone Hydrochloride and Aspirin	Mayne Pharma Inc.	ANDA	Current
68308-845	Oxycodone and Aspirin	Oxycodone Hydrochloride and Aspirin	Mayne Pharma Inc.	ANDA	Current
68308-845	Oxycodone and Aspirin	Oxycodone Hydrochloride and Aspirin	Mayne Pharma Inc.	ANDA	Current
68308-845	Oxycodone and Aspirin	Oxycodone Hydrochloride and Aspirin	Mayne Pharma Inc.	ANDA	Current
68308-845	Oxycodone and Aspirin	Oxycodone Hydrochloride and Aspirin	Mayne Pharma Inc.	ANDA	Current
68308-845	Oxycodone and Aspirin	Oxycodone Hydrochloride and Aspirin	Mayne Pharma Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76109	ORIG	2023-11-02