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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 216533


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NDA 216533 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 216533
Tradename:TIMOLOL MALEATE
Applicant:Ingenus Pharms Llc
Ingredient:timolol maleate
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 216533
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 216533
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TIMOLOL MALEATE timolol maleate SOLUTION/DROPS;OPHTHALMIC 216533 ANDA Ingenus Pharmaceuticals, LLC 50742-287 50742-287-60 15 POUCH in 1 CARTON (50742-287-60) / 4 CONTAINER in 1 POUCH (50742-287-04) / .3 mL in 1 CONTAINER
TIMOLOL MALEATE timolol maleate SOLUTION/DROPS;OPHTHALMIC 216533 ANDA Ingenus Pharmaceuticals, LLC 50742-288 50742-288-60 15 POUCH in 1 CARTON (50742-288-60) / 4 CONTAINER in 1 POUCH (50742-288-04) / .3 mL in 1 CONTAINER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.25% BASE
Approval Date:Sep 13, 2022TE:AT3RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrengthEQ 0.5% BASE
Approval Date:Sep 13, 2022TE:AT3RLD:No

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