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Serving 500+ biopharmaceutical companies globally:

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Generated: June 25, 2017

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 Usl Pharma, Apotex Inc, Akorn, Watson Labs, Pacific Pharma, Teva, Sandoz, Fdc Ltd, Sandoz Inc, Hi Tech Pharma, Quantum Pharmics, Fougera, Mylan, Wockhardt, and Bausch And Lomb, 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. Seventeen suppliers are listed for this compound. Additional details are available on the timolol maleate profile page.

Summary for NDA: 075163

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
SOLUTION/DROPS;OPHTHALMIC 075163 ANDA Hi-Tech Pharmacal Co., Inc. 50383-021 50383-021-05 1 BOTTLE in 1 CARTON (50383-021-05) > 5 mL in 1 BOTTLE
timolol maleate
SOLUTION/DROPS;OPHTHALMIC 075163 ANDA Hi-Tech Pharmacal Co., Inc. 50383-021 50383-021-10 1 BOTTLE in 1 CARTON (50383-021-10) > 10 mL in 1 BOTTLE

Summary 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 500+ biopharmaceutical companies globally:

Farmers Insurance
Boehringer Ingelheim
US Department of Justice
Johnson and Johnson

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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