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Generated: December 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077200

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NDA 077200 describes KETOTIFEN FUMARATE, which is a drug marketed by Akorn, Alcon Pharms Ltd, and Apotex Inc, and is included in three NDAs. It is available from twenty-one suppliers. Additional details are available on the KETOTIFEN FUMARATE profile page.

The generic ingredient in KETOTIFEN FUMARATE is ketotifen fumarate. There are five drug master file entries for this compound. Twenty-three suppliers are listed for this compound. Additional details are available on the ketotifen fumarate profile page.
Summary for 077200
Tradename:KETOTIFEN FUMARATE
Applicant:Alcon Pharms Ltd
Ingredient:ketotifen fumarate
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 077200
Suppliers and Packaging for NDA: 077200
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KETOTIFEN FUMARATE ketotifen fumarate SOLUTION/DROPS;OPHTHALMIC 077200 ANDA Alcon Laboratories, Inc. 0065-4011 0065-4011-05 1 BOTTLE, DROPPER in 1 CARTON (0065-4011-05) > 5 mL in 1 BOTTLE, DROPPER
KETOTIFEN FUMARATE ketotifen fumarate SOLUTION/DROPS;OPHTHALMIC 077200 ANDA Alcon Laboratories, Inc. 0065-4011 0065-4011-06 2 BOTTLE, DROPPER in 1 CARTON (0065-4011-06) > 5 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.025% BASE
Approval Date:Sep 2, 2008TE:RLD:No

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