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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 216361

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NDA 216361 describes BRIMONIDINE TARTRATE, which is a drug marketed by Padagis Israel, Alembic, Apotex, Bausch And Lomb, Dr Reddys Labs Sa, Indoco, Lupin Ltd, Micro Labs, Rising, Sandoz, Somerset Theraps Llc, Teva Parenteral, Upsher Smith Labs, Florida, Glenmark Pharms Ltd, Sentiss, and Somerset, and is included in twenty-six 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. Fourteen suppliers are listed for this compound. Additional details are available on the brimonidine tartrate; timolol maleate profile page.

Summary for 216361

Tradename:	BRIMONIDINE TARTRATE
Applicant:	Dr Reddys Labs Sa
Ingredient:	brimonidine tartrate
Patents:	0

Pharmacology for NDA: 216361

Mechanism of Action	Adrenergic alpha-Agonists

Medical Subject Heading (MeSH) Categories for 216361

Adrenergic alpha-2 Receptor Agonists
Antihypertensive Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.025%
Approval Date:	Feb 16, 2024	TE:		RLD:	No

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