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Last Updated: September 24, 2022

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 two suppliers. There are two patents protecting this drug and one Paragraph IV challenge. 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. Thirty-seven 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:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 021861
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 Novartis Pharmaceuticals Corporation 0078-0834 0078-0834-30 1 BOTTLE in 1 CARTON (0078-0834-30) > 240 SPRAY, METERED in 1 BOTTLE
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:RXDosage:SPRAY, METERED;NASALStrength0.665MG/SPRAY
Approval Date:Apr 15, 2008TE:ABRLD:Yes
Patent:See Plans and PricingPatent Expiration:Aug 2, 2023Product Flag?Substance Flag?Delist Request?Y
Patent:See Plans and PricingPatent Expiration:Mar 17, 2023Product Flag?Substance Flag?Delist Request?Y

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