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Last Updated: April 17, 2026

Details for New Drug Application (NDA): 219219


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NDA 219219 describes BRIMONIDINE TARTRATE, which is a drug marketed by Padagis Israel, Alembic, Apotex, Bausch And Lomb, Dr Reddys Labs Sa, Gland, Lupin Ltd, Micro Labs, Regcon Holdings, Rising, Sandoz, Somerset Theraps Llc, Teva Parenteral, Upsher Smith Labs, Amneal, Caplin, Glenmark Pharms Ltd, Sentiss, and Somerset, and is included in thirty NDAs. It is available from twelve suppliers. Additional details are available on the BRIMONIDINE TARTRATE profile page.

The generic ingredient in BRIMONIDINE TARTRATE is brimonidine tartrate; timolol maleate. There are eleven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the brimonidine tartrate; timolol maleate profile page.
Summary for 219219
Tradename:BRIMONIDINE TARTRATE
Applicant:Gland
Ingredient:brimonidine tartrate
Patents:0
Pharmacology for NDA: 219219
Mechanism of ActionAdrenergic alpha-Agonists
Medical Subject Heading (MeSH) Categories for 219219
Adrenergic alpha-2 Receptor Agonists
Antihypertensive Agents
Suppliers and Packaging for NDA: 219219
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BRIMONIDINE TARTRATE brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 219219 ANDA Gland Pharma Limited 68083-626 68083-626-05 1 BOTTLE in 1 CARTON (68083-626-05) / 5 mL in 1 BOTTLE
BRIMONIDINE TARTRATE brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 219219 ANDA Gland Pharma Limited 68083-626 68083-626-10 1 BOTTLE in 1 CARTON (68083-626-10) / 10 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.1%
Approval Date:Mar 11, 2026TE:ABRLD:No

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Preferred Citation:

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