Last Updated: September 28, 2026

Details for New Drug Application (NDA): 078748

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NDA 078748 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, Alembic Therap, Chartwell Molecular, Epic Pharma Llc, Eugia Pharma, Ingenus Pharms Llc, 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 two drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the dorzolamide hydrochloride; timolol maleate profile page.

Summary for 078748

Tradename:	DORZOLAMIDE HYDROCHLORIDE
Applicant:	Sandoz
Ingredient:	dorzolamide hydrochloride
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 2% BASE
Approval Date:	Nov 6, 2008	TE:	AT	RLD:	No

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