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Generated: April 29, 2017

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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 sixteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. There are six tentative approvals for this compound. Additional details are available on the olopatadine hydrochloride profile page.

Summary for NDA: 206276

Therapeutic Class:Ophthalmic Agents
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
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
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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.7% BASE
Approval Date:Jan 30, 2015TE:RLD:Yes
Patent:9,533,053Patent Expiration:May 19, 2032Product Flag?YSubstance Flag?Delist Request?
Regulatory Exclusivity Expiration:Jan 30, 2018
Regulatory Exclusivity Use:NEW PRODUCT
Regulatory Exclusivity Expiration:Jul 30, 2018
Regulatory Exclusivity Use:PEDIATRIC EXCLUSIVITY

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