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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 216596

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NDA 216596 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 216596

Tradename:	TIMOLOL MALEATE
Applicant:	Micro Labs
Ingredient:	timolol maleate
Patents:	0

Pharmacology for NDA: 216596

Mechanism of Action	Adrenergic beta-Antagonists

Suppliers and Packaging for NDA: 216596

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TIMOLOL MALEATE	timolol maleate	SOLUTION/DROPS;OPHTHALMIC	216596	ANDA	Micro Labs Limited	42571-398	42571-398-71	6 POUCH in 1 CARTON (42571-398-71) / 10 VIAL in 1 POUCH / .3 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	EQ 0.5% BASE
Approval Date:	Sep 7, 2022	TE:	AT3	RLD:	No

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