tafluprost Ophthalmic Solution

Brand(s)
Zioptan
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Akorn (2014-08-31)
Oldest Current Product
2014-11-26
License(s)
NDA
RxNORM
OPHTHALMIC SOLUTION\TAFLUPROST
FDAOB
OPHTHALMIC\SOLUTION_DROPS\TAFLUPROST
SPL Active
OPHTHALMIC\SOLUTION/DROPS\TAFLUPROST
SPL Moiety
OPHTHALMIC\SOLUTION/DROPS\TAFLUPROST

product(s) by strength(s)

tafluprost 0.015 mg/ml ophthalmic solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1174780609ZioptanNDAAkorn2014-11-26TAFLUPROSTOPHTHALMICSOLUTION/DROPSNDA202514a3173c26-0e19-47af-a01c-3fc06b2700d1

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA202514ZIOPTANOAK PHARMACEUTICALS INC2012-02-10p5886035, REDUCTION OF ELEVATED INTRAOCULAR PRESSURE IN PATEINTS WITH OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION, SUBSTANCENEW CHEMICAL ENTITY [2017-02-10]NDA202514_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202514_001RXTAFLUPROST (0.0015%)OPHTHALMICSOLUTION/DROPSTrue2012-02-10ZIOPTAN

patent(s)

#idexpiration dateapplication(s)
1p5886035 (view patent)2017-12-18NDA202514

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1a3173c26-0e19-47af-a01c-3fc06b2700d1 (view SPL)These highlights do not include all the information needed to use ZIOPTAN (tafluprost ophthalmic solution) 0.0015% safely and effectively. See full prescribing information for ZIOPTAN.ZIOPTAN (tafluprost ophthalmic solution) 0.0015%Initial U.S. Approval: 2012prescriptionHuman PrescriptionAkorn2014-08-312174780609
2d51cbf25-003c-4ba7-86cf-921637ef37a0 (view SPL)These highlights do not include all the information needed to use ZIOPTAN (tafluprost ophthalmic solution) 0.0015% safely and effectively. See full prescribing information for ZIOPTAN. ZIOPTAN (tafluprost ophthalmic solution) 0.0015% Initial U.S. Approval: 2012prescriptionHuman PrescriptionMerck Sharp & Dohme Corp.API MANUFACTURE, MANUFACTURE, PACK2013-08-027000063931

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