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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 215004

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NDA 215004 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. Seventeen suppliers are listed for this compound. Additional details are available on the dorzolamide hydrochloride; timolol maleate profile page.

Summary for 215004

Tradename:	DORZOLAMIDE HYDROCHLORIDE
Applicant:	Somerset Theraps Llc
Ingredient:	dorzolamide hydrochloride
Patents:	0

Pharmacology for NDA: 215004

Mechanism of Action	Carbonic Anhydrase Inhibitors

Suppliers and Packaging for NDA: 215004

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DORZOLAMIDE HYDROCHLORIDE	dorzolamide hydrochloride	SOLUTION/DROPS;OPHTHALMIC	215004	ANDA	Somerset Therapeutics, LLC	70069-501	70069-501-01	1 BOTTLE in 1 CARTON (70069-501-01) / 10 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 2% BASE
Approval Date:	Feb 11, 2025	TE:	AT	RLD:	No

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