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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 214645


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NDA 214645 describes TIMOLOL MALEATE, which is a drug marketed by Alembic, Dr Reddys, Eugia Pharma, Gland Pharma Ltd, Sandoz, Akorn, Amring Pharms, Apotex, Apotex Inc, Bausch And Lomb, Epic Pharma Llc, Fdc Ltd, Fougera, Hikma, Ingenus Pharms Llc, Mankind Pharma, Micro Labs, Pacific Pharma, Sentiss Pharma, Ani Pharms, Chartwell Rx, Mylan, Quantum Pharmics, Rising, Teva, Usl Pharma, and Watson Labs, and is included in forty-nine NDAs. It is available from twenty 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-four suppliers are listed for this compound. Additional details are available on the timolol maleate profile page.
Summary for 214645
Tradename:TIMOLOL MALEATE
Applicant:Gland Pharma Ltd
Ingredient:timolol maleate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 214645
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 214645
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIMOLOL MALEATE timolol maleate SOLUTION, GEL FORMING/DROPS;OPHTHALMIC 214645 ANDA Gland Pharma Limited 68083-457 68083-457-01 1 BOTTLE in 1 CARTON (68083-457-01) / 5 mL in 1 BOTTLE
TIMOLOL MALEATE timolol maleate SOLUTION, GEL FORMING/DROPS;OPHTHALMIC 214645 ANDA Gland Pharma Limited 68083-458 68083-458-01 1 BOTTLE in 1 CARTON (68083-458-01) / 5 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION, GEL FORMING/DROPS;OPHTHALMICStrengthEQ 0.25% BASE
Approval Date:Jun 24, 2022TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION, GEL FORMING/DROPS;OPHTHALMICStrengthEQ 0.5% BASE
Approval Date:Feb 14, 2023TE:ABRLD:No

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