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US Army
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Generated: February 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091691

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NDA 091691 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 seven 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. Nine suppliers are listed for this compound. Additional details are available on the brimonidine tartrate profile page.
Summary for 091691
Applicant:Indoco Remedies
Ingredient:brimonidine tartrate
Therapeutic Class:Ophthalmic Agents
Pharmacology for NDA: 091691
Mechanism of ActionAdrenergic alpha-Agonists
Medical Subject Heading (MeSH) Categories for 091691
Suppliers and Packaging for NDA: 091691
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BRIMONIDINE TARTRATE brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 091691 ANDA Osmotica Pharmaceutical Corp. 42843-501 N 42843-501-15
BRIMONIDINE TARTRATE brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 091691 ANDA Osmotica Pharmaceutical Corp. 42843-501 N 42843-501-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.2%
Approval Date:Nov 18, 2014TE:ATRLD:No

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