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Details for New Drug Application (NDA): 076260

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NDA 076260 describes BRIMONIDINE TARTRATE, which is a drug marketed by Akorn, Alcon Pharms Ltd, Bausch And Lomb, Teva Parenteral, Sandoz, and Indoco Remedies, and is included in six NDAs. It is available from ten suppliers. Additional details are available on the BRIMONIDINE TARTRATE profile page.

The generic ingredient in BRIMONIDINE TARTRATE is brimonidine tartrate. There are eleven drug master file entries for this compound. Thirteen suppliers are listed for this compound. There are four tentative approvals for this compound. Additional details are available on the brimonidine tartrate profile page.

Summary for NDA: 076260

Tradename:
BRIMONIDINE TARTRATE
Applicant:
Bausch And Lomb
Ingredient:
brimonidine tartrate
Patents:0
Therapeutic Class:Ophthalmic Agents

Pharmacology for NDA: 076260

Mechanism of ActionAdrenergic alpha-Agonists

Suppliers and Packaging for NDA: 076260

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BRIMONIDINE TARTRATE
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC 076260 ANDA STAT RX USA LLC 16590-883 16590-883-10 10 mL in 1 BOTTLE, DROPPER (16590-883-10)
BRIMONIDINE TARTRATE
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC 076260 ANDA Bausch & Lomb Incorporated 24208-411 24208-411-05 1 BOTTLE, DROPPER in 1 CARTON (24208-411-05) > 5 mL in 1 BOTTLE, DROPPER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.2%
Approval Date:May 28, 2003TE:ATRLD:Yes


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