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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 213757

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NDA 213757 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 Theraps Llc, USV, Zambon Spa, Amneal, Apotex Inc, Hikma, and Padagis Israel, and is included in twenty-five NDAs. It is available from forty-one 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-three suppliers are listed for this compound. Additional details are available on the olopatadine hydrochloride profile page.

Summary for 213757

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

Medical Subject Heading (MeSH) Categories for 213757

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SPRAY, METERED;NASAL			Strength	0.665MG/SPRAY
Approval Date:	Aug 19, 2020	TE:		RLD:	No

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