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Generated: November 17, 2018

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Details for New Drug Application (NDA): 022221

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NDA 022221 describes AKTEN, which is a drug marketed by Akorn and is included in one NDA. It is available from one supplier. There is one patent protecting this drug. Additional details are available on the AKTEN profile page.

The generic ingredient in AKTEN is lidocaine hydrochloride. There are twenty-nine drug master file entries for this compound. Forty-five suppliers are listed for this compound. Additional details are available on the lidocaine hydrochloride profile page.
Summary for 022221
Tradename:AKTEN
Applicant:Akorn
Ingredient:lidocaine hydrochloride
Patents:1
Formulation / Manufacturing:see details
Pharmacology for NDA: 022221
Ingredient-typeAmides
Physiological EffectLocal Anesthesia
Suppliers and Packaging for NDA: 022221
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
AKTEN lidocaine hydrochloride GEL;OPHTHALMIC 022221 NDA Akorn, Inc. 17478-792 17478-792-01 1 TUBE in 1 CARTON (17478-792-01) > 1 mL in 1 TUBE
AKTEN lidocaine hydrochloride GEL;OPHTHALMIC 022221 NDA Akorn, Inc. 17478-792 17478-792-10 1 BOTTLE, DROPPER in 1 CARTON (17478-792-10) > 5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;OPHTHALMICStrength3.5%
Approval Date:Oct 7, 2008TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jul 24, 2026Product Flag?YSubstance Flag?Delist Request?
Patented Use:METHOD OF INDUCING TOPICAL ANESTHESIA IN THE EYE

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Medtronic
Merck
Boehringer Ingelheim
Julphar
Fuji
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Mallinckrodt
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