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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 074465

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NDA 074465 describes TIMOLOL MALEATE, which is a drug marketed by Alembic, Amneal, Dr Reddys, Eugia Pharma, Gland, 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, Pharmobedient, 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-four 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-eight suppliers are listed for this compound. Additional details are available on the timolol maleate profile page.

Summary for 074465

Tradename:	TIMOLOL MALEATE
Applicant:	Epic Pharma Llc
Ingredient:	timolol maleate
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 0.25% BASE
Approval Date:	Mar 25, 1997	TE:		RLD:	No

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