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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 202053


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NDA 202053 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 202053
Tradename:DORZOLAMIDE HYDROCHLORIDE
Applicant:Regcon Holdings
Ingredient:dorzolamide hydrochloride
Patents:0
Pharmacology for NDA: 202053
Mechanism of ActionCarbonic Anhydrase Inhibitors
Suppliers and Packaging for NDA: 202053
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DORZOLAMIDE HYDROCHLORIDE dorzolamide hydrochloride SOLUTION/DROPS;OPHTHALMIC 202053 ANDA Indoco Remedies Limited 14445-404 14445-404-10 1 BOTTLE, DISPENSING in 1 CARTON (14445-404-10) / 10 mL in 1 BOTTLE, DISPENSING
DORZOLAMIDE HYDROCHLORIDE dorzolamide hydrochloride SOLUTION/DROPS;OPHTHALMIC 202053 ANDA Florida Pharmaceutical Products, LLC 71921-400 71921-400-10 10 mL in 1 BOTTLE (71921-400-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 2% BASE
Approval Date:Sep 11, 2014TE:ATRLD:No

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Preferred Citation:

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