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Generated: December 14, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077259

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NDA 077259 describes TIMOLOL MALEATE, which is a drug marketed by Sandoz Inc, Akorn, Apotex Inc, Bausch And Lomb, Fdc Ltd, Fougera, Hi Tech Pharma, Pacific Pharma, Wockhardt, Mylan, Quantum Pharmics, Sandoz, Teva, Usl Pharma, and Watson Labs, and is included in thirty-eight NDAs. It is available from sixteen suppliers. There is one patent protecting this drug. Additional details are available on the TIMOLOL MALEATE profile page.

The generic ingredient in TIMOLOL MALEATE is timolol maleate. There are fifteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the timolol maleate profile page.

Summary for 077259

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Therapeutic Class:Antimigraine Agents
Cardiovascular Agents
Ophthalmic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 077259

Mechanism of ActionAdrenergic beta-Antagonists

Suppliers and Packaging for NDA: 077259

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIMOLOL MALEATE timolol maleate SOLUTION/DROPS;OPHTHALMIC 077259 ANDA FDC Limited 55545-1000 55545-1000-1 1 BOTTLE in 1 CARTON (55545-1000-1) > 5 mL in 1 BOTTLE
TIMOLOL MALEATE timolol maleate SOLUTION/DROPS;OPHTHALMIC 077259 ANDA FDC Limited 55545-1000 55545-1000-3 1 BOTTLE in 1 CARTON (55545-1000-3) > 15 mL in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.25% BASE
Approval Date:Apr 30, 2008TE:ATRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.5% BASE
Approval Date:Apr 30, 2008TE:AT1RLD:No


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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Queensland Health
Fish and Richardson
Moodys
QuintilesIMS
Healthtrust
Farmers Insurance
Cantor Fitzgerald
Accenture
Citi

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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