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Generated: May 27, 2017

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Details for New Drug Application (NDA): 021996

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NDA 021996 describes ALAWAY, which is a drug marketed by Bausch And Lomb and is included in one NDA. It is available from two suppliers. Additional details are available on the ALAWAY profile page.

The generic ingredient in ALAWAY is ketotifen fumarate. There are five drug master file entries for this compound. Thirty-one suppliers are listed for this compound. Additional details are available on the ketotifen fumarate profile page.

Summary for NDA: 021996

Therapeutic Class:Ophthalmic Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 021996

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ketotifen fumarate
SOLUTION/DROPS;OPHTHALMIC 021996 NDA Safeway 21130-601 21130-601-05 1 BOTTLE in 1 CARTON (21130-601-05) > 5 mL in 1 BOTTLE
ketotifen fumarate
SOLUTION/DROPS;OPHTHALMIC 021996 NDA Bausch & Lomb Incorporated 24208-601 24208-601-05 1 BOTTLE, DROPPER in 1 CARTON (24208-601-05) > 5 mL in 1 BOTTLE, DROPPER

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.025% BASE
Approval Date:Dec 1, 2006TE:RLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:OTCDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.035% BASE
Approval Date:Feb 11, 2015TE:RLD:Yes

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