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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

Alcon Pharms Ltd
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
SUSPENSION/DROPS;OPHTHALMIC 021862 NDA Alcon Laboratories, Inc. 0065-0002 0065-0002-01 1.5 mL in 1 BOTTLE, PLASTIC (0065-0002-01)
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?

Expired Orange Book Patents for NDA: 021862

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alcon Pharms Ltd
SUSPENSION/DROPS;OPHTHALMIC021862-001Aug 19, 20055,475,034<subscribe>
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