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Last Updated: July 13, 2020

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Details for New Drug Application (NDA): 020688


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NDA 020688 describes PATADAY TWICE DAILY RELIEF, which is a drug marketed by Novartis and is included in one NDA. It is available from two suppliers. Additional details are available on the PATADAY TWICE DAILY RELIEF profile page.

The generic ingredient in PATADAY TWICE DAILY RELIEF is olopatadine hydrochloride. There are seventeen drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the olopatadine hydrochloride profile page.
Summary for 020688
Tradename:PATADAY TWICE DAILY RELIEF
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
PATADAY TWICE DAILY RELIEF olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 020688 NDA Alcon Laboratories, Inc. 0065-0271 0065-0271-05 5 mL in 1 BOTTLE, PLASTIC (0065-0271-05)
PATADAY TWICE DAILY RELIEF olopatadine hydrochloride SOLUTION/DROPS;OPHTHALMIC 020688 NDA Alcon Laboratories, Inc. 0065-4274 0065-4274-01 1 BOTTLE, PLASTIC in 1 CARTON (0065-4274-01) > 5 mL in 1 BOTTLE, PLASTIC
Paragraph IV (Patent) Challenges for 020688
Tradename Dosage Ingredient NDA Submissiondate
PATADAY TWICE DAILY RELIEF SOLUTION/DROPS;OPHTHALMIC olopatadine hydrochloride 020688 2006-07-17

Profile for product number 001

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

Expired US Patents for NDA 020688

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