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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 090848

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NDA 090848 describes OLOPATADINE HYDROCHLORIDE, which is a drug marketed by Alembic, Apotex, Barr Labs Inc, Bausch And Lomb Inc, Eugia Pharma, Fdc Ltd, Florida, Gland, Glenmark Pharms Inc, Rising, Sciegen Pharms, Somerset, Somerset Theraps Llc, USV, Zambon Spa, Amneal, Apotex Inc, Hikma, and Padagis Israel, and is included in twenty-nine NDAs. It is available from forty-five suppliers. Additional details are available on the OLOPATADINE HYDROCHLORIDE profile page.

The generic ingredient in OLOPATADINE HYDROCHLORIDE is olopatadine hydrochloride. There are seventeen drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the olopatadine hydrochloride profile page.

Summary for 090848

Tradename:	OLOPATADINE HYDROCHLORIDE
Applicant:	Barr Labs Inc
Ingredient:	olopatadine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 090848

Anti-Allergic Agents
Anti-Inflammatory Agents, Non-Steroidal
Histamine H1 Antagonists, Non-Sedating

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 0.2% BASE
Approval Date:	Jul 13, 2015	TE:		RLD:	No

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