Last Updated: June 1, 2026

Details for New Drug Application (NDA): 072668


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NDA 072668 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 072668
Tradename:TIMOLOL MALEATE
Applicant:Mylan
Ingredient:timolol maleate
Patents:0
Pharmacology for NDA: 072668
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 072668
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIMOLOL MALEATE timolol maleate TABLET;ORAL 072668 ANDA Mylan Pharmaceuticals Inc. 0378-0221 0378-0221-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0221-01)

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength20MG
Approval Date:Jun 8, 1990TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength5MG
Approval Date:Jun 8, 1990TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Jun 8, 1990TE:ABRLD:No

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Preferred Citation:

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