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Serving leading biopharmaceutical companies globally:

Harvard Business School
Colorcon
Johnson and Johnson
Novartis
Dow
Queensland Health
Farmers Insurance
AstraZeneca
Deloitte
Cerilliant

Generated: October 20, 2017

DrugPatentWatch Database Preview

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. Sixteen suppliers are listed for this compound. Additional details are available on the olopatadine hydrochloride profile page.

Summary for NDA: 206276

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:2
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
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

Summary 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:► SubscribePatent Expiration:May 19, 2032Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF OCULAR ITCHING ASSOCIATED WITH ALLERGIC CONJUNCTIVITIS


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Serving leading biopharmaceutical companies globally:

UBS
Colorcon
Julphar
Moodys
Argus Health
Merck
US Department of Justice
Chubb
Covington
Baxter

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