MedPath

Brimonidine Tartrate

Approved
Approval ID

bc1785c5-1448-4791-9868-2fbbc8703b3b

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 12, 2010

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

NDC Product Code54868-6094
Application NumberNDA021764
Marketing CategoryC73594
Route of AdministrationOPHTHALMIC
Effective DateJanuary 12, 2010
Generic Namebrimonidine tartrate

INGREDIENTS (12)

BRIMONIDINE TARTRATEActive
Quantity: 1.5 mg in 1 mL
Code: 4S9CL2DY2H
Classification: ACTIB
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
SODIUM BORATEInactive
Code: 91MBZ8H3QO
Classification: IACT
CALCIUM CHLORIDEInactive
Code: M4I0D6VV5M
Classification: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT
MAGNESIUM CHLORIDEInactive
Code: 02F3473H9O
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
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