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FDA Approval

BRIMONIDINE TARTRATE

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Walgreens Company
DUNS: 008965063
Effective Date
August 27, 2024
Labeling Type
Human OTC Drug Label
Brimonidine(0.25 mg in 1 mL)

Products1

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 Code
0363-9960
Application Number
ANDA216361
Marketing Category
ANDA (C73584)
Route of Administration
OPHTHALMIC
Effective Date
August 27, 2024
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7Class: IACT
CALCIUM CHLORIDEInactive
Code: M4I0D6VV5MClass: IACT
Code: 4S9CL2DY2HClass: ACTIBQuantity: 0.25 mg in 1 mL
BORIC ACIDInactive
Code: R57ZHV85D4Class: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10Class: IACT
SODIUM BORATEInactive
Code: 91MBZ8H3QOClass: IACT
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