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Last Updated: April 18, 2024

Details for New Drug Application (NDA): 021861

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NDA 021861 describes PATANASE, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. Additional details are available on the PATANASE profile page.

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

Summary for 021861

Tradename:	PATANASE
Applicant:	Novartis
Ingredient:	olopatadine hydrochloride
Patents:	0
Formulation / Manufacturing:	see details

Medical Subject Heading (MeSH) Categories for 021861

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

Suppliers and Packaging for NDA: 021861

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PATANASE	olopatadine hydrochloride	SPRAY, METERED;NASAL	021861	NDA AUTHORIZED GENERIC	Sandoz Inc	61314-320	61314-320-01	1 BOTTLE in 1 CARTON (61314-320-01) / 30500 uL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SPRAY, METERED;NASAL			Strength	0.665MG/SPRAY
Approval Date:	Apr 15, 2008	TE:		RLD:	Yes

Expired US Patents for NDA 021861

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	PATANASE	olopatadine hydrochloride	SPRAY, METERED;NASAL	021861-001	Apr 15, 2008	⤷ Try a Trial	⤷ Try a Trial
Novartis	PATANASE	olopatadine hydrochloride	SPRAY, METERED;NASAL	021861-001	Apr 15, 2008	⤷ Try a Trial	⤷ Try a Trial
Novartis	PATANASE	olopatadine hydrochloride	SPRAY, METERED;NASAL	021861-001	Apr 15, 2008	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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