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Last Updated: April 23, 2025

Details for New Drug Application (NDA): 204392

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NDA 204392 describes OLOPATADINE HYDROCHLORIDE, which is a drug marketed by Alembic, Apotex, Barr Labs Inc, Bausch And Lomb Inc, Eugia Pharma, Fdc Ltd, Florida, Gland Pharma Ltd, Glenmark Pharms Inc, Rising, Sciegen Pharms Inc, Somerset, Somerset Theraps Llc, USV, Zambon Spa, Amneal, Apotex Inc, Hikma, and Padagis Israel, and is included in twenty-seven NDAs. It is available from forty-two 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-four suppliers are listed for this compound. Additional details are available on the olopatadine hydrochloride profile page.

Summary for 204392

Tradename:	OLOPATADINE HYDROCHLORIDE
Applicant:	Rising
Ingredient:	olopatadine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 204392

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 0.1% BASE
Approval Date:	Mar 21, 2018	TE:		RLD:	No

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