Betamethasone / calcipotriene Topical Foam

Brand(s)
Enstilar
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Leo Pharma Inc. (2015-10-29)
Oldest Current Product
2015-10-16
License(s)
NDA
RxNORM
TOPICAL FOAM\BETAMETHASONE:CALCIPOTRIENE
FDAOB
TOPICAL\AEROSOL, FOAM\BETAMETHASONE DIPROPIONATE: CALCIPOTRIENE
SPL Active
TOPICAL\AEROSOL, FOAM\BETAMETHASONE DIPROPIONATE: CALCIPOTRIENE HYDRATE
SPL Moiety
TOPICAL\AEROSOL, FOAM\BETAMETHASONE: CALCIPOTRIENE

product(s) by strength(s)

betamethasone dipropionate 0.643 mg/ml / calcipotriene 0.05 mg/ml topical foam

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1502220302EnstilarNDALeo Pharma Inc.2015-10-16BETAMETHASONE DIPROPIONATE, CALCIPOTRIENE HYDRATETOPICALAEROSOL, FOAMNDA207589d1193df2-d53f-4342-bd9d-d9cba7c89709

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA207589ENSTILARLEO PHARMA AS2015-10-16p9119781, PLAQUE PSORIASIS, SUBSTANCE
p6753013, PLAQUE PSORIASIS, SUBSTANCE
NEW PRODUCT [2018-10-16]NDA207589_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA207589_001RXCALCIPOTRIENE (0.005%), BETAMETHASONE DIPROPIONATE (0.064%)TOPICALAEROSOL, FOAMTrue2015-10-16ENSTILAR

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6753013 (view patent)2020-01-27NDA207589, NDA021852, NDA022185Betamethasone / calcipotriene Topical Ointment
Betamethasone / calcipotriene Topical Lotion
2p9119781 (view patent)2031-06-10NDA207589

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1d1193df2-d53f-4342-bd9d-d9cba7c89709 (view SPL)These highlights do not include all the information needed to use ENSTILARFoam safely and effectively. See Full Prescribing Information for ENSTILARFoam. ENSTILAR (calcipotriene and betamethasone dipropionate)Foam, 0.005%/0.064% for topical use Initial U.S. Approval: 2006prescriptionHuman PrescriptionLeo Pharma Inc.manufacture2015-10-292502220302

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