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Dow
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Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075163

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NDA 075163 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 fifteen 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. Eighteen suppliers are listed for this compound. Additional details are available on the timolol maleate profile page.
Summary for 075163
Tradename:TIMOLOL MALEATE
Applicant:Hi Tech Pharma
Ingredient:timolol maleate
Patents:0
Therapeutic Class:Antimigraine Agents
Cardiovascular Agents
Ophthalmic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075163
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 075163
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIMOLOL MALEATE timolol maleate SOLUTION/DROPS;OPHTHALMIC 075163 ANDA Hi-Tech Pharmacal Co., Inc. 50383-021 N 50383-021-05
TIMOLOL MALEATE timolol maleate SOLUTION/DROPS;OPHTHALMIC 075163 ANDA Hi-Tech Pharmacal Co., Inc. 50383-021 N 50383-021-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.5% BASE
Approval Date:Sep 10, 2002TE:AT1RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

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