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Serving leading biopharmaceutical companies globally:

US Army
Express Scripts

Generated: January 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076254

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NDA 076254 describes BRIMONIDINE TARTRATE, which is a drug marketed by Akorn, Bausch And Lomb, Indoco Remedies, Sandoz Inc, and Teva Parenteral, and is included in six NDAs. It is available from eight 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. Ten suppliers are listed for this compound. Additional details are available on the brimonidine tartrate profile page.
Summary for 076254
Applicant:Sandoz Inc
Ingredient:brimonidine tartrate
Therapeutic Class:Ophthalmic Agents
Pharmacology for NDA: 076254
Mechanism of ActionAdrenergic alpha-Agonists
Medical Subject Heading (MeSH) Categories for 076254
Suppliers and Packaging for NDA: 076254
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BRIMONIDINE TARTRATE brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 076254 ANDA Sandoz Inc 61314-143 61314-143-15 15 mL in 1 BOTTLE (61314-143-15)
BRIMONIDINE TARTRATE brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 076254 ANDA Sandoz Inc 61314-143 61314-143-10 10 mL in 1 BOTTLE (61314-143-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.2%
Approval Date:Sep 16, 2003TE:ATRLD:No

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Serving leading biopharmaceutical companies globally:

Argus Health
Cantor Fitzgerald

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