Application 204092

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	SOLUTION;ORAL	100MG/5ML	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68094-801	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Precision Dose, Inc.	ANDA	Current
68094-801	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Precision Dose, Inc.	ANDA	Current
68094-801	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Precision Dose, Inc.	ANDA	Current
68094-801	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Precision Dose, Inc.	ANDA	Current
68094-801	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Precision Dose, Inc.	ANDA	Current
68308-020	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Mayne Pharma Inc.	ANDA	Current
68308-020	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Mayne Pharma Inc.	ANDA	Current
68308-020	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Mayne Pharma Inc.	ANDA	Current
68308-020	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Mayne Pharma Inc.	ANDA	Current
70166-492	Oxycodone Hydrochloride	Oxycodone Hydrochloride	Lohxa	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
76113	ORIG	2023-11-02