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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Chubb
McKinsey
Moodys
Baxter
Deloitte
Queensland Health
Farmers Insurance
US Army

Generated: April 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078981

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NDA 078981 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 seven 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. Nine suppliers are listed for this compound. Additional details are available on the dorzolamide hydrochloride; timolol maleate profile page.
Summary for 078981
Tradename:DORZOLAMIDE HYDROCHLORIDE
Applicant:Sandoz Inc
Ingredient:dorzolamide hydrochloride
Patents:0
Therapeutic Class:Ophthalmic Agents
Pharmacology for NDA: 078981
Mechanism of ActionCarbonic Anhydrase Inhibitors
Suppliers and Packaging for NDA: 078981
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DORZOLAMIDE HYDROCHLORIDE dorzolamide hydrochloride SOLUTION/DROPS;OPHTHALMIC 078981 ANDA Sandoz Inc 61314-019 N 61314-019-10
DORZOLAMIDE HYDROCHLORIDE dorzolamide hydrochloride SOLUTION/DROPS;OPHTHALMIC 078981 ANDA Sandoz Inc 61314-019 N 61314-019-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 2% BASE
Approval Date:Apr 13, 2009TE:ATRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
McKinsey
Queensland Health
Teva
Medtronic
US Army
Baxter
Daiichi Sankyo
Merck

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