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Details for New Drug Application (NDA): 077958

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NDA 077958 describes KETOTIFEN FUMARATE, which is a drug marketed by Alcon Pharms Ltd, Apotex Inc, and Akorn, and is included in three NDAs. It is available from twenty-nine 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. Thirty-one suppliers are listed for this compound. Additional details are available on the ketotifen fumarate profile page.

Summary for NDA: 077958

Tradename:
KETOTIFEN FUMARATE
Applicant:
Akorn
Ingredient:
ketotifen fumarate
Patents:0
Therapeutic Class:Ophthalmic Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 077958

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
KETOTIFEN FUMARATE
ketotifen fumarate
SOLUTION/DROPS;OPHTHALMIC 077958 ANDA L Perrigo Company 0113-0027 0113-0027-01 1 BOTTLE in 1 CARTON (0113-0027-01) > 5 mL in 1 BOTTLE
KETOTIFEN FUMARATE
ketotifen fumarate
SOLUTION/DROPS;OPHTHALMIC 077958 ANDA L Perrigo Company 0113-0615 0113-0615-01 1 BOTTLE in 1 CARTON (0113-0615-01) > 5 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.025% BASE
Approval Date:Jul 26, 2007TE: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.

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