Last Updated: November 8, 2026

Details for New Drug Application (NDA): 213215

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NDA 213215 describes BRIMONIDINE TARTRATE, which is a drug marketed by Padagis Israel, Alembic, Apotex, Bausch And Lomb Inc, Dr Reddys Labs Sa, Gland, Lupin, Mankind Pharma, Micro Labs, Regcon Holdings, Rising, Sandoz, Somerset Theraps Llc, Teva Parenteral, Upsher Smith Labs, Amneal, Caplin, Glenmark Pharms Ltd, Saba Ilac Sanayive, Sentiss, and Somerset, and is included in thirty-four NDAs. It is available from fourteen suppliers. Additional details are available on the BRIMONIDINE TARTRATE profile page.

The generic ingredient in BRIMONIDINE TARTRATE is brimonidine tartrate; timolol maleate. There are two drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the brimonidine tartrate; timolol maleate profile page.

Summary for 213215

Tradename:	BRIMONIDINE TARTRATE
Applicant:	Lupin
Ingredient:	brimonidine tartrate
Patents:	0

Medical Subject Heading (MeSH) Categories for 213215

Adrenergic alpha-2 Receptor Agonists
Antihypertensive Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.1%
Approval Date:	Aug 26, 2024	TE:	AB	RLD:	No

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