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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 074515


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NDA 074515 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 074515
Tradename:TIMOLOL MALEATE
Applicant:Epic Pharma Llc
Ingredient:timolol maleate
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.25% BASE
Approval Date:Mar 25, 1997TE:RLD:No

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