Details for New Drug Application (NDA): 215520

NDA 215520 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 Pharma Ltd, Hikma, Indoco, Ingenus Pharms Llc, Micro Labs, Rubicon, Sandoz, Somerset, Teva Pharms, and Zambon Spa, and is included in nineteen 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. Eighteen suppliers are listed for this compound. Additional details are available on the dorzolamide hydrochloride; timolol maleate profile page.

Summary for 215520

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

Pharmacology for NDA: 215520

Mechanism of Action

Adrenergic beta-Antagonists Carbonic Anhydrase Inhibitors

Suppliers and Packaging for NDA: 215520

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE	dorzolamide hydrochloride; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	215520	ANDA	Gland Pharma Limited	68083-490	68083-490-01	1 BOTTLE in 1 CARTON (68083-490-01) / 10 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 2% BASE;EQ 0.5% BASE
Approval Date:	Sep 19, 2022	TE:	AT1	RLD:	No

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