brinzolamide Ophthalmic Suspension

Brand(s)
Azopt
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Alcon Laboratories, Inc. (2012-03-08)
Oldest Current Product
1998-04-30
License(s)
NDA
RxNORM
OPHTHALMIC SUSPENSION\BRINZOLAMIDE
FDAOB
OPHTHALMIC\SUSPENSION_DROPS\BRINZOLAMIDE
SPL Active
OPHTHALMIC\SUSPENSION\BRINZOLAMIDE
SPL Moiety
OPHTHALMIC\SUSPENSION\BRINZOLAMIDE

product(s) by strength(s)

brinzolamide 10 mg/ml ophthalmic suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000650275AzoptNDAAlcon Laboratories, Inc.1998-04-30BRINZOLAMIDEOPHTHALMICSUSPENSIONNDA020816e9ea2ae7-1b98-4034-9fba-8ce2225e0145

application(s)

#idtitleapplicantapprovedapproved drug
1NDA020816AZOPTALCON PHARMACEUTICALS LTD1998-04-01NDA020816_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA020816_001RXBRINZOLAMIDE (1%)OPHTHALMICSUSPENSION/DROPSTrue1998-04-01AZOPT

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1e9ea2ae7-1b98-4034-9fba-8ce2225e0145 (view SPL)These highlights do not include all the information needed to use AZOPT safely and effectively. See full prescribing information for AZOPT. AZOPT (brinzolamide ophthalmic suspension) 1% Sterile topical ophthalmic drops Initial U.S. Approval: 1998prescriptionHuman PrescriptionAlcon Laboratories, Inc.MANUFACTURE2012-03-086000650275

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII