Details for New Drug Application (NDA): 215598

NDA 215598 describes BRIMONIDINE TARTRATE AND TIMOLOL MALEATE, which is a drug marketed by Alembic, Apotex, Florida, Glenmark Pharms Ltd, Sandoz, Sentiss, Somerset, and Upsher Smith Labs, and is included in eight NDAs. It is available from eleven 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 215598

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

Pharmacology for NDA: 215598

Mechanism of Action

Adrenergic alpha-Agonists Adrenergic beta-Antagonists

Suppliers and Packaging for NDA: 215598

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	215598	ANDA	Upsher-Smith Laboratories, LLC	0832-1425	0832-1425-05	1 BOTTLE, DROPPER in 1 CARTON (0832-1425-05) / 5 mL in 1 BOTTLE, DROPPER
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	215598	ANDA	Upsher-Smith Laboratories, LLC	0832-1425	0832-1425-10	1 BOTTLE, DROPPER in 1 CARTON (0832-1425-10) / 10 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION/DROPS;OPHTHALMIC			Strength	0.2%;EQ 0.5% BASE
Approval Date:	Dec 12, 2022	TE:	AB	RLD:	No

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