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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 215660


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NDA 215660 describes DORZOLAMIDE HYDROCHLORIDE, which is a drug marketed by Alembic, Am Regent, Bausch And Lomb, Fdc Ltd, Gland, Hikma, Micro Labs, Regcon Holdings, Rubicon Research, Sandoz, Somerset Theraps Llc, Teva Pharms, Zambon Spa, Chartwell Molecular, Epic Pharma Llc, Eugia Pharma, Ingenus Pharms Llc, New Heightsrx, and Somerset, and is included in thirty-four NDAs. It is available from fourteen suppliers. Additional details are available on the DORZOLAMIDE HYDROCHLORIDE profile page.

The generic ingredient in DORZOLAMIDE HYDROCHLORIDE is dorzolamide hydrochloride; 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 dorzolamide hydrochloride; timolol maleate profile page.
Summary for 215660
Tradename:DORZOLAMIDE HYDROCHLORIDE
Applicant:Gland
Ingredient:dorzolamide hydrochloride
Patents:0
Pharmacology for NDA: 215660
Mechanism of ActionCarbonic Anhydrase Inhibitors
Suppliers and Packaging for NDA: 215660
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DORZOLAMIDE HYDROCHLORIDE dorzolamide hydrochloride SOLUTION/DROPS;OPHTHALMIC 215660 ANDA Sagent Pharmaceuticals 25021-006 25021-006-10 1 BOTTLE in 1 CARTON (25021-006-10) / 10 mL in 1 BOTTLE
DORZOLAMIDE HYDROCHLORIDE dorzolamide hydrochloride SOLUTION/DROPS;OPHTHALMIC 215660 ANDA Gland Pharma Limited 68083-489 68083-489-01 1 BOTTLE in 1 CARTON (68083-489-01) / 10 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 2% BASE
Approval Date:Jan 27, 2022TE:ATRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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