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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 205309

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NDA 205309 describes TIMOLOL, which is a drug marketed by Epic Pharma Llc, Somerset, Alembic, Amneal, Dr Reddys, Eugia Pharma, Gland, Sandoz, Somerset Theraps Llc, Amring Pharms, Apotex, Apotex Inc, Bausch And Lomb, Caplin, Fdc Ltd, Fougera, Hikma, Ingenus Pharms Llc, Mankind Pharma, Micro Labs, Pacific Pharma, Pharmobedient, Sentiss Pharma, Ani Pharms, Chartwell Rx, Mylan, Quantum Pharmics, Rising, Teva, Usl Pharma, and Watson Labs, and is included in fifty-six NDAs. It is available from one supplier. Additional details are available on the TIMOLOL profile page.

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

Summary for 205309

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

Medical Subject Heading (MeSH) Categories for 205309

Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.25%
Approval Date:	Sep 30, 2016	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.5%
Approval Date:	Sep 30, 2016	TE:		RLD:	No

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