Brimonidine Tartrate
These highlights do not include all the information needed to use BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION, 0.2% safely and effectively. See full prescribing information for Brimonidine tartrate ophthalmic solution, 0.2% Brimonidine tartrate ophthalmic solution, 0.2% For Topical Ophthalmic Use Initial U.S. Approval: 1996
Approved
Approval ID
383421a5-5d33-4f15-88f4-8b66fcbfac71
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2018
Manufacturers
FDA
Indoco Remedies Limited
DUNS: 650445950
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Brimonidine Tartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code14445-400
Application NumberANDA091691
Product Classification
M
Marketing Category
C73584
G
Generic Name
Brimonidine Tartrate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateDecember 27, 2018
FDA Product Classification
INGREDIENTS (9)
Sodium CitrateInactive
Code: 1Q73Q2JULR
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Benzalkonium ChlorideInactive
Code: F5UM2KM3W7
Classification: IACT
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT
Citric Acid MonohydrateInactive
Code: 2968PHW8QP
Classification: IACT
BRIMONIDINE TARTRATEActive
Quantity: 2 mg in 1 mg
Code: 4S9CL2DY2H
Classification: ACTIB
Polyvinyl AlcoholInactive
Code: 532B59J990
Classification: IACT
Hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
Sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT