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Last Updated: July 5, 2020

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Details for New Drug Application (NDA): 021862


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NDA 021862 describes NEVANAC, which is a drug marketed by Novartis and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the NEVANAC profile page.

The generic ingredient in NEVANAC is nepafenac. There are eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the nepafenac profile page.
Summary for 021862
Tradename:NEVANAC
Applicant:Novartis
Ingredient:nepafenac
Patents:3
Pharmacology for NDA: 021862
Mechanism of ActionCyclooxygenase Inhibitors
Suppliers and Packaging for NDA: 021862
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEVANAC nepafenac SUSPENSION/DROPS;OPHTHALMIC 021862 NDA Alcon Laboratories, Inc. 0065-0002 0065-0002-03 3 mL in 1 BOTTLE, PLASTIC (0065-0002-03)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OPHTHALMICStrength0.1%
Approval Date:Aug 19, 2005TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jan 31, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING OCULAR INFLAMMATION
Patent:  Start TrialPatent Expiration:Dec 2, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Dec 2, 2025Product Flag?YSubstance Flag?Delist Request?

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