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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
Sandoz Inc
DUNS: 005387188
Effective Date
May 31, 2021
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Brimonidine(1.5 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
61314-144
Application Number
NDA021764
Marketing Category
NDA (C73594)
Route of Administration
OPHTHALMIC
Effective Date
November 17, 2011
Code: 4S9CL2DY2HClass: ACTIBQuantity: 1.5 mg in 1 mL
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94EClass: IACT
BORIC ACIDInactive
Code: R57ZHV85D4Class: IACT
SODIUM BORATEInactive
Code: 91MBZ8H3QOClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
MANNITOLInactive
Code: 3OWL53L36AClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
CALCIUM CHLORIDEInactive
Code: M4I0D6VV5MClass: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10Class: IACT
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