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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 078075

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NDA 078075 describes BRIMONIDINE TARTRATE, which is a drug marketed by Padagis Israel, Alembic, Apotex, Bausch And Lomb, Dr Reddys Labs Sa, 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 twenty-nine NDAs. It is available from eleven 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. Fifteen suppliers are listed for this compound. Additional details are available on the brimonidine tartrate; timolol maleate profile page.

Summary for 078075

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

Medical Subject Heading (MeSH) Categories for 078075

Adrenergic alpha-2 Receptor Agonists
Antihypertensive Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.2%
Approval Date:	Jan 30, 2008	TE:	AT	RLD:	No

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