Application 090848

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OLOPATADINE HYDROCHLORIDE	OLOPATADINE HYDROCHLORIDE	SOLUTION/DROPS;OPHTHALMIC	EQ 0.2% BASE	No	No

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-7684	Olopatadine Hydrochloride	Olopatadine Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7684	Olopatadine Hydrochloride	Olopatadine Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-7684	Olopatadine Hydrochloride	Olopatadine Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
67172-504	Clear Eyes	Olopatadine hydrochloride	Prestige Brands Holdings, Inc.	ANDA	Current
67172-504	Clear Eyes Once Daily Eye Allergy Itch Relief	Olopatadine hydrochloride	Prestige Brands Holdings, Inc.	ANDA	Current

Document, Submission type, Date table
Document	Submission type	Date
39613	ORIG	2015-07-22
31503	ORIG	2015-07-15