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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 078480


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NDA 078480 describes BRIMONIDINE TARTRATE, which is a drug marketed by Padagis Israel, Alembic, Apotex, Bausch And Lomb, Indoco, Micro Labs, Rising, Sandoz, Somerset Theraps Llc, Teva Parenteral, Florida, Sentiss, and Upsher Smith Labs, and is included in nineteen NDAs. It is available from eleven 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 078480
Tradename:BRIMONIDINE TARTRATE
Applicant:Apotex
Ingredient:brimonidine tartrate
Patents:0
Pharmacology for NDA: 078480
Mechanism of ActionAdrenergic alpha-Agonists
Medical Subject Heading (MeSH) Categories for 078480
Suppliers and Packaging for NDA: 078480
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BRIMONIDINE TARTRATE brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 078480 ANDA Apotex Corp. 60505-0577 60505-0577-1 1 BOTTLE, DROPPER in 1 CARTON (60505-0577-1) / 5 mL in 1 BOTTLE, DROPPER
BRIMONIDINE TARTRATE brimonidine tartrate SOLUTION/DROPS;OPHTHALMIC 078480 ANDA Apotex Corp. 60505-0577 60505-0577-2 1 BOTTLE, DROPPER in 1 CARTON (60505-0577-2) / 10 mL in 1 BOTTLE, DROPPER

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION/DROPS;OPHTHALMICStrength0.1%
Approval Date:Dec 21, 2022TE:ABRLD:No

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