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Details for New Drug Application (NDA): 076439

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NDA 076439 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: 076439

brimonidine tartrate
Therapeutic Class:Ophthalmic Agents

Pharmacology for NDA: 076439

Mechanism of ActionAdrenergic alpha-Agonists

Suppliers and Packaging for NDA: 076439

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC 076439 ANDA Akorn, Inc. 17478-715 17478-715-10 1 BOTTLE, DROPPER in 1 CARTON (17478-715-10) > 5 mL in 1 BOTTLE, DROPPER
brimonidine tartrate
SOLUTION/DROPS;OPHTHALMIC 076439 ANDA Akorn, Inc. 17478-715 17478-715-11 1 BOTTLE, DROPPER in 1 CARTON (17478-715-11) > 10 mL in 1 BOTTLE, DROPPER

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.2%
Approval Date:Mar 14, 2006TE:ATRLD:No

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.