travoprost Ophthalmic Solution

Brand(s)
Travatan
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Alcon Laboratories, Inc. (2011-08-17)
Oldest Current Product
2006-10-20
License(s)
NDA, ANDA
RxNORM
OPHTHALMIC SOLUTION\TRAVOPROST
FDAOB
OPHTHALMIC\SOLUTION_DROPS\TRAVOPROST
SPL Active
OPHTHALMIC\SOLUTION/DROPS\TRAVOPROST
OPHTHALMIC\SOLUTION\TRAVOPROST
SPL Moiety
OPHTHALMIC\SOLUTION/DROPS\TRAVOPROST
OPHTHALMIC\SOLUTION\TRAVOPROST

product(s) by strength(s)

travoprost 0.04 mg/ml ophthalmic solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000650260TravatanNDAAlcon Laboratories, Inc.2006-10-20TRAVOPROSTOPHTHALMICSOLUTION/DROPSNDA0219945549684b-1724-45ca-b67b-590c62b7c149

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1498840044ANDAPar Pharmaceutical Companies, Inc.2013-04-15TRAVOPROSTOPHTHALMICSOLUTIONANDA09134061987047-f322-4477-8a82-4d61fbd8bb37

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685968TravatanNDAPhysicians Total Care, Inc.2008-12-09TRAVOPROSTOPHTHALMICSOLUTION000650260NDA021994db08d5f3-6713-4372-a66c-fad3018ef5c6

application(s)

#idtitledeprecatedapplicantapprovedpatentexclusivityapproved drug
1ANDA091340TRAVOPROSTPAR PHARMACEUTICAL INC2013-03-01ANDA091340_001
2ANDA203431TRAVOPROSTAPOTEX INC2015-07-10ANDA203431_001
3NDA021257TRAVATANTrueALCON PHARMACEUTICALS LTD2001-03-16p5849792, METHOD FOR TREATING GLAUCOMA AND OCULAR HYPERTENSION, SUBSTANCE
p6011062, SUBSTANCE
p5631287, METHOD OF STABLIZING PROSTAGLANDIN
p5889052, METHOD FOR TREATING GLAUCOMA AND OCULAR HYPERTENSION, SUBSTANCE
NDA021257_001
4NDA021994TRAVATAN ZALCON PHARMACEUTICALS LTD2006-09-21p8323630, SUBSTANCE
p8268299, SUBSTANCE
p8388941, SUBSTANCE
p5889052, METHOD FOR TREATING GLAUCOMA AND OCULAR HYPERTENSION, SUBSTANCE
NDA021994_001
5NDA204822IZBATrueALCON LABORATORIES INC2014-05-15p9144561, SUBSTANCE
p8178582, SUBSTANCE
p8754123, SUBSTANCE
p8722735, SUBSTANCE
NEW PRODUCT [2017-05-15]NDA204822_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA091340_001RXTRAVOPROST (0.004%)OPHTHALMICSOLUTION/DROPSTrue2013-03-01TRAVOPROST
2ANDA203431_001RXTRAVOPROST (0.004%)OPHTHALMICSOLUTION/DROPSFalseAT2015-07-10TRAVOPROST
3NDA021257_001discontinuedTRAVOPROST (0.004%)OPHTHALMICSOLUTION/DROPSFalse2001-03-16TRAVATAN
4NDA021994_001RXTRAVOPROST (0.004%)OPHTHALMICSOLUTION/DROPSTrueAT2006-09-21TRAVATAN Z
5NDA204822_001discontinuedTRAVOPROST (0.003%)OPHTHALMICSOLUTION/DROPSFalse2014-05-15IZBA

patent(s)

#idexpiration dateapplication(s)
1p5631287 (view patent)2014-12-22NDA021257
2p5849792 (view patent)2014-12-22NDA021257
3p5889052 (view patent)2014-12-02NDA021257, NDA021994
4p6011062 (view patent)2014-12-22NDA021257
5p8178582 (view patent)2029-10-10NDA204822
6p8268299 (view patent)2029-10-13NDA021994
7p8323630 (view patent)2027-09-20NDA021994
8p8388941 (view patent)2027-09-20NDA021994
9p8722735 (view patent)2029-10-10NDA204822
10p8754123 (view patent)2029-05-19NDA204822
11p9144561 (view patent)2029-03-13NDA204822

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
15549684b-1724-45ca-b67b-590c62b7c149 (view SPL)These highlights do not include all the information needed to use TRAVATANZ (travoprost ophthalmic solution) 0.004% safely and effectively. See full prescribing information for TRAVATAN Z.TRAVATAN Z (travoprost ophthalmic solution) 0.004%Initial U.S. Approval: 2001prescriptionHuman PrescriptionAlcon Laboratories, Inc.MANUFACTURE2011-08-1711000650260
261987047-f322-4477-8a82-4d61fbd8bb37 (view SPL)These highlights do not include all the information needed to use Travoprost Ophthalmic Solution USP, 0.004% safely and effectively. See full prescribing information for Travoprost Ophthalmic Solution USP, 0.004%.Initial U.S. Approval: 2001prescriptionHuman PrescriptionPar Pharmaceutical Companies, Inc.2013-04-222498840044
3db08d5f3-6713-4372-a66c-fad3018ef5c6 (view SPL)These highlights do not include all the information needed to use TRAVATAN Z (travoprost ophthalmic solution) 0.004% safely and effectively. See full prescribing information for TRAVATAN Z . TRAVATAN Z (travoprost ophthalmic solution) 0.004% Initial U.S. Approval: 2001prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2011-07-201548685968

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