Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Alcon Research, LLC
007672236
Manufacturing Establishments2
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Alcon Research, LLC
Alcon Laboratories, Inc.
Alcon Research, LLC
007672236
S.A. Alcon-Couvreur N.V.
Alcon Laboratories, Inc.
Alcon Research, LLC
370205429
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SIMBRINZA
Product Details
NDC Product Code
0065-4147Application Number
NDA204251Marketing Category
NDA (C73594)Route of Administration
OPHTHALMICEffective Date
May 16, 2023BrinzolamideActive
Code: 9451Z89515Class: ACTIBQuantity: 10 mg in 1 mL
BrimonidineActive
Code: 4S9CL2DY2HClass: ACTIBQuantity: 2 mg in 1 mL
MannitolInactive
Code: 3OWL53L36AClass: IACT
Benzalkonium ChlorideInactive
Code: F5UM2KM3W7Class: IACT
Carbomer Homopolymer Type B (allyl Pentaerythritol Crosslinked)Inactive
Code: HHT01ZNK31Class: IACT
Boric AcidInactive
Code: R57ZHV85D4Class: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3Class: IACT
Sodium ChlorideInactive
Code: 451W47IQ8XClass: IACT
TyloxapolInactive
Code: Y27PUL9H56Class: IACT
WaterInactive
Code: 059QF0KO0RClass: IACT
Hydrochloric AcidInactive
Code: QTT17582CBClass: IACT
Sodium HydroxideInactive
Code: 55X04QC32IClass: IACT