Details for New Drug Application (NDA): 216654

NDA 216654 describes TIMOLOL, which is a drug marketed by Epic Pharma Llc, Somerset, Alembic, Amneal, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, 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, Sciegen Pharms Inc, 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-nine suppliers are listed for this compound. Additional details are available on the timolol maleate profile page.

Summary for 216654

Tradename:	TIMOLOL
Applicant:	Somerset
Ingredient:	timolol
Patents:	0

Pharmacology for NDA: 216654

Mechanism of Action

Adrenergic beta-Antagonists

Medical Subject Heading (MeSH) Categories for 216654

Adrenergic beta-Antagonists

Anti-Arrhythmia Agents

Antihypertensive Agents

Suppliers and Packaging for NDA: 216654

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TIMOLOL	timolol	SOLUTION/DROPS;OPHTHALMIC	216654	ANDA	Somerset Therapeutics, LLC	70069-696	70069-696-01	1 BOTTLE in 1 CARTON (70069-696-01) / 5 mL in 1 BOTTLE
TIMOLOL	timolol	SOLUTION/DROPS;OPHTHALMIC	216654	ANDA	Somerset Therapeutics, LLC	70069-697	70069-697-01	1 BOTTLE in 1 CARTON (70069-697-01) / 10 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.5%
Approval Date:	Oct 10, 2024	TE:	AT	RLD:	No

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