brimonidine / brinzolamide Ophthalmic Suspension

Brand(s)
Simbrinza
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Alcon Laboratories, Inc. (2014-05-20)
Oldest Current Product
2013-05-01
License(s)
NDA
RxNORM
OPHTHALMIC SUSPENSION\BRIMONIDINE:BRINZOLAMIDE
FDAOB
OPHTHALMIC\SUSPENSION_DROPS\BRIMONIDINE TARTRATE: BRINZOLAMIDE
SPL Active
OPHTHALMIC\SUSPENSION/DROPS\BRIMONIDINE TARTRATE: BRINZOLAMIDE
SPL Moiety
OPHTHALMIC\SUSPENSION/DROPS\BRIMONIDINE: BRINZOLAMIDE

product(s) by strength(s)

brimonidine tartrate 2 mg/ml / brinzolamide 10 mg/ml ophthalmic suspension

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000654147SimbrinzaNDAAlcon Laboratories, Inc.2013-05-01BRIMONIDINE TARTRATE, BRINZOLAMIDEOPHTHALMICSUSPENSION/DROPSNDA204251a49c157e-6310-0011-7b7f-e26fc1820d59

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA204251SIMBRINZAALCON RESEARCH LTD2013-04-19p6316441, REDUCTION OF ELEVATED INTRAOCULAR PRESSURE IN PATEINTS WITH OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION
p9044484, SUBSTANCE
NEW COMBINATION [2016-04-19]NDA204251_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA204251_001RXBRIMONIDINE TARTRATE (0.2%), BRINZOLAMIDE (1%)OPHTHALMICSUSPENSION/DROPSTrue2013-04-19SIMBRINZA

patent(s)

#idexpiration dateapplication(s)
1p6316441 (view patent)2019-12-07NDA204251
2p9044484 (view patent)2030-10-30NDA204251

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1a49c157e-6310-0011-7b7f-e26fc1820d59 (view SPL)These highlights do not include all the information needed to useSIMBRINZA safely and effectively. See full prescribing information for SIMBRINZA. SIMBRINZA (brinzolamide/brimonidine tartrate ophthalmic suspension) 1%/0.2%Initial U.S. Approval: 2013prescriptionHuman PrescriptionAlcon Laboratories, Inc.MANUFACTURE2014-05-208000654147

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