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Generated: April 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074746

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NDA 074746 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, Teva, Usl Pharma, Watson Labs, and Yaopharma Co Ltd, and is included in thirty-eight NDAs. It is available from thirteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the timolol maleate profile page.
Summary for 074746
Tradename:TIMOLOL MALEATE
Applicant:Pacific Pharma
Ingredient:timolol maleate
Patents:0
Therapeutic Class:Antimigraine Agents
Cardiovascular Agents
Ophthalmic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 074746
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 074746
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIMOLOL MALEATE timolol maleate SOLUTION/DROPS;OPHTHALMIC 074746 ANDA Pacific Pharma, Inc. 60758-802 N 60758-802-05
TIMOLOL MALEATE timolol maleate SOLUTION/DROPS;OPHTHALMIC 074746 ANDA Pacific Pharma, Inc. 60758-802 N 60758-802-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.25% BASE
Approval Date:Mar 25, 1997TE:ATRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Federal Trade Commission
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Julphar
US Army
UBS
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Baxter
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Harvard Business School

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