Application 203107

Type: ANDA
Sponsor: MAYNE PHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	CAPSULE;ORAL	5MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68308-145	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Mayne Pharma Inc.	ANDA	Current
68308-145	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Mayne Pharma Inc.	ANDA	Current
68308-145	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Mayne Pharma Inc.	ANDA	Current
68308-145	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Mayne Pharma Inc.	ANDA	Current
68308-145	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Mayne Pharma Inc.	ANDA	Current
68308-145	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Mayne Pharma Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76111	ORIG	2023-11-02