Last Updated: June 17, 2026

Details for New Drug Application (NDA): 218558

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NDA 218558 describes BRIMONIDINE TARTRATE, which is a drug marketed by Padagis Israel, Alembic, Apotex, Bausch And Lomb, 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, Sentiss, and Somerset, and is included in thirty-two NDAs. It is available from thirteen 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. Thirteen suppliers are listed for this compound. Additional details are available on the brimonidine tartrate; timolol maleate profile page.

Summary for 218558

Tradename:	BRIMONIDINE TARTRATE
Applicant:	Micro Labs
Ingredient:	brimonidine tartrate
Patents:	0

Medical Subject Heading (MeSH) Categories for 218558

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:	May 7, 2026	TE:	AB	RLD:	No

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