Timolol Ophthalmic Gel

Brand(s)
Timoptic
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Aton Pharma, Inc. (2014-12-23)
Oldest Current Product
1993-11-14
License(s)
NDA
RxNORM
OPHTHALMIC GEL\TIMOLOL
FDAOB
OPHTHALMIC\SOLUTION, GEL FORMING_DROPS\TIMOLOL MALEATE
SPL Active
OPHTHALMIC\SOLUTION, GEL FORMING, EXTENDED RELEASE\TIMOLOL MALEATE
OPHTHALMIC\SOLUTION\TIMOLOL MALEATE
SPL Moiety
OPHTHALMIC\SOLUTION, GEL FORMING, EXTENDED RELEASE\TIMOLOL: TIMOLOL ANHYDROUS
OPHTHALMIC\SOLUTION\TIMOLOL ANHYDROUS
OPHTHALMIC\SOLUTION\TIMOLOL: TIMOLOL ANHYDROUS

product(s) by strength(s)

timolol 0.0025 mg/mg ophthalmic gel

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1250100810TimopticNDAAton Pharma, Inc.1993-11-14TIMOLOL MALEATEOPHTHALMICSOLUTIONNDA02033032e96044-2713-40f2-b6f7-c342a31382d8
2613140224NDASandoz Inc1998-12-24TIMOLOL MALEATEOPHTHALMICSOLUTION, GEL FORMING, EXTENDED RELEASENDA02096372b0d0ec-832a-4c25-b845-2537ab506354

timolol 0.005 mg/mg ophthalmic gel

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1250100811TimopticNDAAton Pharma, Inc.1993-11-14TIMOLOL MALEATEOPHTHALMICSOLUTIONNDA02033032e96044-2713-40f2-b6f7-c342a31382d8
2250100817NDAAton Pharma, Inc.1993-11-14TIMOLOL MALEATEOPHTHALMICSOLUTIONNDA0203304386a2d5-f577-4768-9efe-7d11a8938644

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1521250475NDARemedyrepack Inc.2013-12-03TIMOLOL MALEATEOPHTHALMICSOLUTION250100817NDA02033011268176-a549-43d4-a683-beab6dec0d0a
2548684691NDAPhysicians Total Care, Inc.2002-10-16TIMOLOL MALEATEOPHTHALMICSOLUTION250100817NDA02033075b3b776-5eb8-4381-ade1-5cf0e942d5ed

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA020330TIMOPTIC-XEVALEANT PHARMACEUTICALS NORTH AMERICA LLC1993-11-04NDA020330_001, NDA020330_002
2NDA020963TIMOLOL MALEATEALCON RESEARCH LTD1998-10-21p6174524, SUBSTANCENDA020963_001, NDA020963_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1NDA020330_001RXTIMOLOL MALEATE (EQ 0.25% BASE)OPHTHALMICSOLUTION, GEL FORMING/DROPSTrueAB1993-11-04TIMOPTIC-XE
2NDA020330_002RXTIMOLOL MALEATE (EQ 0.5% BASE)OPHTHALMICSOLUTION, GEL FORMING/DROPSTrueAB1993-11-04TIMOPTIC-XE
3NDA020963_001RXTIMOLOL MALEATE (EQ 0.25% BASE)OPHTHALMICSOLUTION, GEL FORMING/DROPSFalseAB1998-10-21TIMOLOL MALEATE
4NDA020963_002RXTIMOLOL MALEATE (EQ 0.5% BASE)OPHTHALMICSOLUTION, GEL FORMING/DROPSFalseAB1998-10-21TIMOLOL MALEATE

patent(s)

#idexpiration dateapplication(s)
1p6174524 (view patent)2019-03-26NDA020963

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
111268176-a549-43d4-a683-beab6dec0d0a (view SPL)TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION 0.25% AND 0.5%prescriptionHuman PrescriptionRemedyrepack Inc.2013-12-031521250475
232e96044-2713-40f2-b6f7-c342a31382d8 (view SPL)TIMOPTIC-XE 0.25% AND 0.5% (TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION)prescriptionHuman PrescriptionAton Pharma, Inc.MANUFACTURE2014-12-193250100810, 250100811
34386a2d5-f577-4768-9efe-7d11a8938644 (view SPL)TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION 0.25% AND 0.5%prescriptionHuman PrescriptionAton Pharma, Inc.MANUFACTURE2014-12-232250100817, 250100816
472b0d0ec-832a-4c25-b845-2537ab506354 (view SPL)These highlights do not include all the information needed to use Timolol GFS safely and effectively. See full prescribing information for Timolol GFS.Timolol GFS (timolol maleate ophthalmic gel forming solution) 0.25% and 0.5%, Sterile topical ophthalmic dropsInitial U.S. Approval: 1978prescriptionHuman PrescriptionSandoz Inc2011-12-1410613140224, 613140225
575b3b776-5eb8-4381-ade1-5cf0e942d5ed (view SPL)TIMOLOL MALEATE OPHTHALMIC GEL FORMING SOLUTION 0.25% AND 0.5%prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-08-291548684691

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