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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 Alcon Pharms Ltd and is included in one NDA. It is available from two suppliers. 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. Two suppliers are listed for this compound. Additional details are available on the nepafenac profile page.

Summary for NDA: 021862

Tradename:
NEVANAC
Applicant:
Alcon Pharms Ltd
Ingredient:
nepafenac
Patents:3
Therapeutic Class:Ophthalmic Agents

Pharmacology for NDA: 021862

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 0065-0002-01 1.5 mL in 1 BOTTLE, PLASTIC (0065-0002-01)
NEVANAC
nepafenac
SUSPENSION/DROPS;OPHTHALMIC 021862 NDA Alcon Laboratories, Inc. 0065-0002 0065-0002-03 3 mL in 1 BOTTLE, PLASTIC (0065-0002-03)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUSPENSION/DROPS;OPHTHALMICStrength0.1%
Approval Date:Aug 19, 2005TE:RLD:Yes
Patent:8,071,648Patent Expiration:Dec 2, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:8,324,281Patent Expiration:Dec 2, 2025Product Flag?YSubstance Flag?Delist Request?
Patent:7,834,059Patent Expiration:Jan 31, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING OCULAR INFLAMMATION

Expired Orange Book Patents for NDA: 021862

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alcon Pharms Ltd
NEVANAC
nepafenac
SUSPENSION/DROPS;OPHTHALMIC021862-001Aug 19, 20055,475,034► subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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