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Generated: November 12, 2018

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Details for New Drug Application (NDA): 206276

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NDA 206276 describes PAZEO, which is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the PAZEO profile page.

The generic ingredient in PAZEO is olopatadine hydrochloride. There are seventeen drug master file entries for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the olopatadine hydrochloride profile page.
Summary for 206276
Tradename:PAZEO
Applicant:Novartis Pharms Corp
Ingredient:olopatadine hydrochloride
Patents:2
Formulation / Manufacturing:see details
Pharmacology for NDA: 206276
Suppliers and Packaging for NDA: 206276
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PAZEO olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 206276 NDA Alcon Laboratories, Inc. 0065-4273 0065-4273-25 1 BOTTLE, DROPPER in 1 CARTON (0065-4273-25) > 2.5 mL in 1 BOTTLE, DROPPER
PAZEO olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 206276 NDA Alcon Laboratories, Inc. 0065-4273 0065-4273-27 1 BOTTLE, DROPPER in 1 CARTON (0065-4273-27) > .5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.7% BASE
Approval Date:Jan 30, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 30, 2018
Regulatory Exclusivity Use:NEW PRODUCT
Regulatory Exclusivity Expiration:Jul 30, 2018
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY
Patent:➤ Sign UpPatent Expiration:May 19, 2032Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF OCULAR ITCHING ASSOCIATED WITH ALLERGIC CONJUNCTIVITIS

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