Details for New Drug Application (NDA): 201949

NDA 201949 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 ten 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. Thirteen suppliers are listed for this compound. Additional details are available on the brimonidine tartrate; timolol maleate profile page.

Summary for 201949

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

Pharmacology for NDA: 201949

Mechanism of Action

Adrenergic alpha-Agonists Adrenergic beta-Antagonists

Suppliers and Packaging for NDA: 201949

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	201949	ANDA	Florida Pharmaceutical Products, LLC	71921-188	71921-188-05	1 BOTTLE, DROPPER in 1 CARTON (71921-188-05) / 5 mL in 1 BOTTLE, DROPPER
BRIMONIDINE TARTRATE AND TIMOLOL MALEATE	brimonidine tartrate; timolol maleate	SOLUTION/DROPS;OPHTHALMIC	201949	ANDA	Florida Pharmaceutical Products, LLC	71921-188	71921-188-10	1 BOTTLE, DROPPER in 1 CARTON (71921-188-10) / 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:	Oct 4, 2022	TE:	AB	RLD:	No

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