Brimonidine Tartrate
Brimonidine Tartrate Ophthalmic Solution 0.2% (Sterile)
Approved
Approval ID
5316cf97-e38e-4e78-aff2-c6972a666f3d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 19, 2013
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-6287
Application NumberANDA076260
Product Classification
M
Marketing Category
C73584
G
Generic Name
Brimonidine Tartrate
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateFebruary 19, 2013
FDA Product Classification
INGREDIENTS (9)
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
BRIMONIDINE TARTRATEActive
Quantity: 2 mg in 1 mL
Code: 4S9CL2DY2H
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT