Last Updated: June 25, 2026

Details for New Drug Application (NDA): 078981

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NDA 078981 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 078981

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

Pharmacology for NDA: 078981

Mechanism of Action	Carbonic Anhydrase Inhibitors

Suppliers and Packaging for NDA: 078981

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DORZOLAMIDE HYDROCHLORIDE	dorzolamide hydrochloride	SOLUTION/DROPS;OPHTHALMIC	078981	ANDA	Sandoz Inc	61314-019	61314-019-10	10 mL in 1 BOTTLE (61314-019-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 2% BASE
Approval Date:	Apr 13, 2009	TE:	AT	RLD:	No

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