Details for New Drug Application (NDA): 217288

NDA 217288 describes BRIMONIDINE TARTRATE AND TIMOLOL MALEATE, which is a drug marketed by Alembic, Amneal, Apotex, Caplin, Florida, Glenmark Pharms Ltd, Sandoz, Sentiss, Somerset, and Upsher Smith Labs, and is included in ten NDAs. It is available from twelve suppliers. Additional details are available on the BRIMONIDINE TARTRATE AND TIMOLOL MALEATE profile page.

The generic ingredient in BRIMONIDINE TARTRATE AND TIMOLOL MALEATE 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 217288

Tradename:	BRIMONIDINE TARTRATE AND TIMOLOL MALEATE
Applicant:	Amneal
Ingredient:	brimonidine tartrate; timolol maleate
Patents:	0

Pharmacology for NDA: 217288

Mechanism of Action

Adrenergic alpha-Agonists Adrenergic beta-Antagonists

Suppliers and Packaging for NDA: 217288

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	217288	ANDA	Amneal Pharmaceuticals NY LLC	60219-2067	60219-2067-3	1 BOTTLE in 1 CARTON (60219-2067-3) / 5 mL in 1 BOTTLE
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	217288	ANDA	Amneal Pharmaceuticals NY LLC	60219-2068	60219-2068-6	1 BOTTLE in 1 CARTON (60219-2068-6) / 10 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.2%;EQ 0.5% BASE
Approval Date:	Dec 30, 2024	TE:		RLD:	No

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