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Last Updated: December 13, 2025

Details for New Drug Application (NDA): 078749

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NDA 078749 describes DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, which is a drug marketed by Alembic, Bausch And Lomb, Chartwell Molecular, Epic Pharma Llc, Eugia Pharma, Fdc Ltd, Gland, Hikma, Ingenus Pharms Llc, Micro Labs, New Heightsrx, Regcon Holdings, Rubicon Research, Sandoz, Somerset, Teva Pharms, and Zambon Spa, and is included in twenty NDAs. It is available from sixteen suppliers. Additional details are available on the DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE profile page.

The generic ingredient in DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE 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 078749

Tradename:	DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
Applicant:	Sandoz
Ingredient:	dorzolamide hydrochloride; timolol maleate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 2% BASE;EQ 0.5% BASE
Approval Date:	Nov 6, 2008	TE:	AT1	RLD:	No

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