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Last Updated: May 30, 2020

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, Somerset Theraps Llc, and Teva Parenteral, and is included in seven NDAs. It is available from six 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. Eight suppliers are listed for this compound. Additional details are available on the brimonidine tartrate profile page.
Summary for 091691
Tradename:BRIMONIDINE TARTRATE
Applicant:Indoco Remedies
Ingredient:brimonidine tartrate
Patents:0
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 Indoco Remedies Limited 14445-400 14445-400-05 5 mg in 1 BOTTLE, PLASTIC (14445-400-05)
BRIMONIDINE TARTRATE brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 091691 ANDA Indoco Remedies Limited 14445-400 14445-400-10 10 mg in 1 BOTTLE, PLASTIC (14445-400-10)

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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