Brimonidine Tartrate and Timolol Maleate

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Labeler

Alembic Pharmaceuticals Limited

DUNS Number

675480734

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

46708-706

Application Number

ANDA215230

Marketing Category

ANDA (C73584)

Route of Administration

OPHTHALMIC

Effective Date

August 31, 2023

Ingredients

Code: 4S9CL2DY2HClass: ACTIBQuantity: 2 mg in 1 mL

Code: P8Y54F701RClass: ACTIMQuantity: 5 mg in 1 mL

BENZALKONIUM CHLORIDEInactive

Code: F5UM2KM3W7Class: IACT

SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATEInactive

Code: 593YOG76RNClass: IACT

SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATEInactive

Code: 70WT22SF4BClass: IACT

WATERInactive

Code: 059QF0KO0RClass: IACT

HYDROCHLORIC ACIDInactive

Code: QTT17582CBClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT