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Last Updated: April 17, 2026

Details for New Drug Application (NDA): 216909


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NDA 216909 describes BRIMONIDINE TARTRATE, which is a drug marketed by Padagis Israel, Alembic, Apotex, Bausch And Lomb, Dr Reddys Labs Sa, Gland, Lupin Ltd, Micro Labs, Regcon Holdings, Rising, Sandoz, Somerset Theraps Llc, Teva Parenteral, Upsher Smith Labs, Amneal, Caplin, Glenmark Pharms Ltd, Sentiss, and Somerset, and is included in thirty NDAs. It is available from twelve suppliers. Additional details are available on the BRIMONIDINE TARTRATE profile page.

The generic ingredient in BRIMONIDINE TARTRATE is brimonidine tartrate; timolol maleate. There are eleven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the brimonidine tartrate; timolol maleate profile page.
Summary for 216909
Tradename:BRIMONIDINE TARTRATE
Applicant:Alembic
Ingredient:brimonidine tartrate
Patents:0
Pharmacology for NDA: 216909
Mechanism of ActionAdrenergic alpha-Agonists
Medical Subject Heading (MeSH) Categories for 216909
Adrenergic alpha-2 Receptor Agonists
Antihypertensive Agents
Suppliers and Packaging for NDA: 216909
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BRIMONIDINE TARTRATE brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 216909 ANDA Alembic Pharmaceuticals Limited 46708-749 46708-749-05 1 BOTTLE in 1 CARTON (46708-749-05) / 5 mL in 1 BOTTLE
BRIMONIDINE TARTRATE brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 216909 ANDA Alembic Pharmaceuticals Limited 46708-749 46708-749-10 1 BOTTLE in 1 CARTON (46708-749-10) / 10 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.1%
Approval Date:Aug 1, 2023TE:ABRLD: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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification 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.

 
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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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