calcipotriene Topical Foam

Brand(s)
Sorilux
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Stiefel Laboratories Inc (2013-09-30)
Oldest Current Product
2010-10-26
License(s)
NDA
RxNORM
TOPICAL FOAM\CALCIPOTRIENE
FDAOB
TOPICAL\AEROSOL, FOAM\CALCIPOTRIENE
SPL Active
TOPICAL\AEROSOL, FOAM\CALCIPOTRIENE
SPL Moiety
TOPICAL\AEROSOL, FOAM\CALCIPOTRIENE

product(s) by strength(s)

calcipotriene 0.05 mg/ml topical foam

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1001452130SoriluxNDAStiefel Laboratories Inc2010-10-26CALCIPOTRIENETOPICALAEROSOL, FOAMNDA022563c376bc8b-e046-4011-bb20-2cfda38d6cb8

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA022563SORILUXSTIEFEL LABORATORIES INC2010-10-06p8269128, USE OF A CALCIPOTRIENE CONTAINING FOAM FOR THE TREATMENT OF PSORIASIS, SUBSTANCE
p8263580, USE OF A CALCIPOTRIENE CONTAINING FOAM FOR THE TREATMENT OF PSORIASIS, SUBSTANCE
PLAQUE PSORIASIS OF THE SCALP [2015-09-27]NDA022563_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022563_001RXCALCIPOTRIENE (0.005%)TOPICALAEROSOL, FOAMTrue2010-10-06SORILUX

patent(s)

#idexpiration dateapplication(s)
1p8263580 (view patent)2028-09-27NDA022563
2p8269128 (view patent)2026-05-26NDA022563

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1c376bc8b-e046-4011-bb20-2cfda38d6cb8 (view SPL)These highlights do not include all the information needed to use SORILUX safely and effectively. See full prescribing information for SORILUX. SORILUX (calcipotriene) foam, 0.005%, for topical use Initial U.S. Approval: 1993prescriptionHuman PrescriptionStiefel Laboratories Inc2013-09-3011001452130

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