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Last Updated: August 1, 2021

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Details for New Drug Application (NDA): 077259

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NDA 077259 describes TIMOLOL MALEATE, which is a drug marketed by Alembic Pharms Ltd, Sandoz Inc, Akorn, Apotex, Apotex Inc, Bausch And Lomb, Fdc Ltd, Fougera, Mankind Pharma, Pacific Pharma, Ani Pharms, Elysium, Mylan, Quantum Pharmics, Teva, Usl Pharma, Watson Labs, and Yaopharma Co Ltd, and is included in forty-one NDAs. It is available from fourteen 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. Seventeen suppliers are listed for this compound. Additional details are available on the timolol maleate profile page.
Summary for 077259
Applicant:Fdc Ltd
Ingredient:timolol maleate
Formulation / Manufacturing:see details
Pharmacology for NDA: 077259
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 077259
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIMOLOL MALEATE timolol maleate SOLUTION/DROPS;OPHTHALMIC 077259 ANDA Medsource Pharmaceuticals 45865-121 45865-121-01 1 BOTTLE in 1 CARTON (45865-121-01) > 5 mL in 1 BOTTLE
TIMOLOL MALEATE timolol maleate SOLUTION/DROPS;OPHTHALMIC 077259 ANDA A-S Medication Solutions 50090-5091 50090-5091-0 1 BOTTLE in 1 CARTON (50090-5091-0) > 5 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.25% BASE
Approval Date:Apr 30, 2008TE:ATRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.5% BASE
Approval Date:Apr 30, 2008TE:AT1RLD:No

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