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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 072919

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NDA 072919 describes TIMOLOL MALEATE, which is a drug marketed by Alembic, Amneal, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Sandoz, Somerset Theraps Llc, Amring Pharms, Apotex, Apotex Inc, Bausch And Lomb, Caplin, Epic Pharma Llc, Fdc Ltd, Fougera, Hikma, Ingenus Pharms Llc, Mankind Pharma, Micro Labs, Pacific Pharma, Sciegen Pharms Inc, Sentiss Pharma, Somerset, Ani Pharms, Chartwell Rx, Mylan, Quantum Pharmics, Rising, Teva, Usl Pharma, and Watson Labs, and is included in fifty-four NDAs. It is available from twenty-five suppliers. Additional details are available on the TIMOLOL MALEATE profile page.

The generic ingredient in TIMOLOL MALEATE is timolol maleate. There are fifteen drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the timolol maleate profile page.

Summary for 072919

Tradename:	TIMOLOL MALEATE
Applicant:	Ani Pharms
Ingredient:	timolol maleate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Jul 31, 1991	TE:		RLD:	No

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