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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-two suppliers are listed for this compound. Additional details are available on the ketotifen fumarate profile page.

Summary for NDA: 021996

Bausch And Lomb
ketotifen fumarate
Therapeutic Class:Ophthalmic Agents

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:No

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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.