Details for New Drug Application (NDA): 090143

NDA 090143 describes DORZOLAMIDE HYDROCHLORIDE, which is a drug marketed by Alembic, Am Regent, Bausch And Lomb, Fdc Ltd, Gland Pharma Ltd, Hikma, Indoco, Micro Labs, Rubicon, Sandoz, Teva Pharms, Zambon Spa, Chartwell Molecular, Epic Pharma Llc, Eugia Pharma, Ingenus Pharms Llc, and Somerset, and is included in thirty-two NDAs. It is available from twelve 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. Eighteen suppliers are listed for this compound. Additional details are available on the dorzolamide hydrochloride; timolol maleate profile page.

Summary for 090143

Tradename:	DORZOLAMIDE HYDROCHLORIDE
Applicant:	Bausch And Lomb
Ingredient:	dorzolamide hydrochloride
Patents:	0

Pharmacology for NDA: 090143

Mechanism of Action

Carbonic Anhydrase Inhibitors

Suppliers and Packaging for NDA: 090143

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DORZOLAMIDE HYDROCHLORIDE	dorzolamide hydrochloride	SOLUTION/DROPS;OPHTHALMIC	090143	ANDA	Bausch & Lomb Incorporated	24208-485	24208-485-10	1 BOTTLE, DROPPER in 1 CARTON (24208-485-10) / 10 mL in 1 BOTTLE, DROPPER
DORZOLAMIDE HYDROCHLORIDE	dorzolamide hydrochloride	SOLUTION/DROPS;OPHTHALMIC	090143	ANDA	A-S Medication Solutions	50090-2406	50090-2406-0	1 BOTTLE, DROPPER in 1 CARTON (50090-2406-0) / 10 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 2% BASE
Approval Date:	Jun 25, 2009	TE:	AT	RLD:	No

Complete Access Available with Subscription