Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Apotex Inc.
209429182
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Apotex Inc.
Apotex Corp.
Apotex Inc.
255092496
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
60505-0564Application Number
ANDA078479Marketing Category
ANDA (C73584)Route of Administration
OPHTHALMICEffective Date
December 13, 2023BrimonidineActive
Code: 4S9CL2DY2HClass: ACTIBQuantity: 1.5 mg in 1 mL
boric acidInactive
Code: R57ZHV85D4Class: IACT
calcium chlorideInactive
Code: M4I0D6VV5MClass: IACT
magnesium chlorideInactive
Code: 02F3473H9OClass: IACT
potassium chlorideInactive
Code: 660YQ98I10Class: IACT
sodium borateInactive
Code: 91MBZ8H3QOClass: IACT
waterInactive
Code: 059QF0KO0RClass: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311Class: IACT
sodium chlorideInactive
Code: 451W47IQ8XClass: IACT
hydrochloric acidInactive
Code: QTT17582CBClass: IACT
sodium hydroxideInactive
Code: 55X04QC32IClass: IACT
sodium chloriteInactive
Code: G538EBV4VFClass: IACT