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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Express Scripts
Farmers Insurance
Argus Health
Fish and Richardson

Generated: March 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078756

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NDA 078756 describes DORZOLAMIDE HYDROCHLORIDE, which is a drug marketed by Apotex Inc, Bausch And Lomb, Hi Tech Pharma, Luitpold, Sandoz Inc, Teva Pharms, Watson Labs Inc, Zambon Spa, Akorn Inc, Lannett Holdings Inc, and Sandoz, and is included in nineteen NDAs. It is available from nine suppliers. Additional details are available on the DORZOLAMIDE HYDROCHLORIDE profile page.

The generic ingredient in DORZOLAMIDE HYDROCHLORIDE is dorzolamide hydrochloride; timolol maleate. There are fourteen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the dorzolamide hydrochloride; timolol maleate profile page.
Summary for 078756
Applicant:Teva Pharms
Ingredient:dorzolamide hydrochloride
Therapeutic Class:Ophthalmic Agents
Pharmacology for NDA: 078756
Mechanism of ActionCarbonic Anhydrase Inhibitors
Suppliers and Packaging for NDA: 078756
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DORZOLAMIDE HYDROCHLORIDE dorzolamide hydrochloride SOLUTION/DROPS;OPHTHALMIC 078756 ANDA Teva Pharmaceuticals USA, Inc. 0093-7618 N 0093-7618-43

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 2% BASE
Approval Date:Dec 4, 2008TE:ATRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Army
Daiichi Sankyo
Express Scripts

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