ORCHID HLTHCARE Application 090044

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	TABLET;ORAL	5MG	No	No
002	MEMANTINE HYDROCHLORIDE	MEMANTINE HYDROCHLORIDE	TABLET;ORAL	10MG	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68820-068	Mematine Hydrochloride	Mematine Hydrochloride	Orchid Chemicals & Pharmaceuticals Limited	ANDA	Current
68820-069	Mematine Hydrochloride	Mematine Hydrochloride	Orchid Chemicals & Pharmaceuticals Limited	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
9252	ORIG	2016-02-18
31445	ORIG	2010-01-15