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Last Updated: November 18, 2019

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Details for New Drug Application (NDA): 020688

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NDA 020688 describes PATANOL, which is a drug marketed by Novartis and is included in one NDA. It is available from three suppliers. Additional details are available on the PATANOL profile page.

The generic ingredient in PATANOL is olopatadine hydrochloride. There are seventeen drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the olopatadine hydrochloride profile page.
Summary for 020688
Tradename:PATANOL
Applicant:Novartis
Ingredient:olopatadine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020688
Suppliers and Packaging for NDA: 020688
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PATANOL olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 020688 NDA Alcon Laboratories, Inc. 0065-0271 0065-0271-05 5 mL in 1 BOTTLE, PLASTIC (0065-0271-05)
PATANOL olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 020688 NDA A-S Medication Solutions 50090-0593 50090-0593-0 5 mL in 1 BOTTLE, PLASTIC (50090-0593-0)
Paragraph IV (Patent) Challenges for 020688
Tradename Dosage Ingredient NDA Submissiondate
PATANOL SOLUTION/DROPS;OPHTHALMIC olopatadine hydrochloride 020688 2006-07-17

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.1% BASE
Approval Date:Dec 18, 1996TE:ATRLD:Yes

Expired US Patents for NDA 020688

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis PATANOL olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 020688-001 Dec 18, 1996   Start Trial   Start Trial
Novartis PATANOL olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 020688-001 Dec 18, 1996   Start Trial   Start Trial
Novartis PATANOL olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 020688-001 Dec 18, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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