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Last Updated: July 29, 2021

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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-nine suppliers are listed for this compound. Additional details are available on the olopatadine hydrochloride profile page.
Summary for 021861
Ingredient:olopatadine hydrochloride
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 Alcon Laboratories, Inc. 0065-0332 0065-0332-08 1 BOTTLE in 1 CARTON (0065-0332-08) > 8 SPRAY, METERED in 1 BOTTLE
PATANASE olopatadine hydrochloride SPRAY, METERED;NASAL 021861 NDA Alcon Laboratories, Inc. 0065-0332 0065-0332-30 1 BOTTLE in 1 CARTON (0065-0332-30) > 240 SPRAY, METERED in 1 BOTTLE
Paragraph IV (Patent) Challenges for 021861
Tradename Dosage Ingredient NDA Submissiondate
PATANASE SPRAY, METERED;NASAL olopatadine hydrochloride 021861 2009-06-29

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SPRAY, METERED;NASALStrength0.665MG/SPRAY
Approval Date:Apr 15, 2008TE:ABRLD:Yes
Patent:⤷  Try it FreePatent Expiration:Aug 2, 2023Product Flag?Substance Flag?Delist Request?Y
Patent:⤷  Try it FreePatent Expiration:Mar 17, 2023Product Flag?Substance Flag?Delist Request?Y

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Serving leading biopharmaceutical companies globally:

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