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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 218460


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NDA 218460 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-two 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-five suppliers are listed for this compound. Additional details are available on the timolol maleate profile page.
Summary for 218460
Tradename:TIMOLOL MALEATE
Applicant:Caplin
Ingredient:timolol maleate
Patents:0
Pharmacology for NDA: 218460
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 218460
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIMOLOL MALEATE timolol maleate SOLUTION/DROPS;OPHTHALMIC 218460 ANDA A-S Medication Solutions 50090-7837 50090-7837-0 1 BOTTLE in 1 CARTON (50090-7837-0) / 10 mL in 1 BOTTLE
TIMOLOL MALEATE timolol maleate SOLUTION/DROPS;OPHTHALMIC 218460 ANDA Caplin Steriles Limited 65145-152 65145-152-01 1 BOTTLE in 1 CARTON (65145-152-01) / 5 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.5% BASE
Approval Date:Aug 7, 2024TE:AT1RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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