isopropyl unoprostone Ophthalmic Solution

Brand(s)
Eescula
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Sucampo Pharma Americas, Llc (2013-01-04)
Oldest Current Product
2013-01-07
License(s)
NDA
RxNORM
OPHTHALMIC SOLUTION\ISOPROPYL UNOPROSTONE
FDAOB
OPHTHALMIC\SOLUTION_DROPS\UNOPROSTONE ISOPROPYL
SPL Active
OPHTHALMIC\SOLUTION/DROPS\UNOPROSTONE ISOPROPYL
SPL Moiety
OPHTHALMIC\SOLUTION/DROPS\UNOPROSTONE

product(s) by strength(s)

isopropyl unoprostone 1.5 mg/ml ophthalmic solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1173500015EesculaNDASucampo Pharma Americas, Llc2013-01-07UNOPROSTONE ISOPROPYLOPHTHALMICSOLUTION/DROPSNDA02121453d05ced-51dd-11de-8a39-0800200c9a66

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA021214RESCULAR-TECH UENO LTD2000-08-03p6458836, METHOD OF TREATING OCULAR HYPERTENSION/ THE LONG TERM TREATMENT OF PROPHYLACTIC MANAGEMENT OF OCULAR HYPERTENSION AND GLAUCOMA
p6770675, METHOD OF REDUCING OCULAR HYPERTENSION, SUBSTANCE
NDA021214_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA021214_001RXUNOPROSTONE ISOPROPYL (0.15%)OPHTHALMICSOLUTION/DROPSTrue2000-08-03RESCULA

patent(s)

#idexpiration dateapplication(s)
1p6458836 (view patent)2021-07-09NDA021214
2p6770675 (view patent)2018-11-24NDA021214

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
153d05ced-51dd-11de-8a39-0800200c9a66 (view SPL)These highlights do not include all the information needed to use RESCULA safely and effectively. See full prescribing information for RESCULA. Rescula (unoprostone isopropyl ophthalmic solution) 0.15% Initial U.S. Approval: 2000prescriptionHuman PrescriptionSucampo Pharma Americas, Llc2013-01-043173500015

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