Azelate Topical Foam

Brand(s)
Finacea
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Bayer Healthcare Pharmaceuticals Inc. (2015-07-29)
Oldest Current Product
2015-08-03
License(s)
NDA
RxNORM
TOPICAL FOAM\AZELATE
FDAOB
TOPICAL\AEROSOL, FOAM\AZELAIC ACID
SPL Active
TOPICAL\AEROSOL, FOAM\AZELAIC ACID
SPL Moiety
TOPICAL\AEROSOL, FOAM\AZELAIC ACID

product(s) by strength(s)

azelaic acid 150 mg/ml topical foam

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504190829FinaceaNDABayer Healthcare Pharmaceuticals Inc.2015-08-03AZELAIC ACIDTOPICALAEROSOL, FOAMNDA207071d3f44051-9a13-4bcf-9783-f09286d86f4f

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA207071FINACEA BAYER HEALTHCARE PHARMACEUTICALS INC2015-07-29p8900554, SUBSTANCE
p8435498, TOPICAL TREATMENT OF INFLAMMATORY PAPULES AND PUSTULES OF MILD TO MODERATE ROSACEA
p8722021, SUBSTANCE
p6730288, SUBSTANCE
p7700076, SUBSTANCE
NEW PRODUCT [2018-07-29]NDA207071_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA207071_001RXAZELAIC ACID (15%)TOPICALAEROSOL, FOAMTrue2015-07-29FINACEA

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p6730288 (view patent)2019-09-08NDA207071, NDA021978, NDA022013Desonide Topical Foam
Clobetasol Topical Foam
2p7700076 (view patent)2027-09-18NDA207071
3p8435498 (view patent)2024-03-01NDA207071
4p8722021 (view patent)2023-10-24NDA207071
5p8900554 (view patent)2023-10-24NDA207071

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1d3f44051-9a13-4bcf-9783-f09286d86f4f (view SPL)These highlights do not include all the information needed to use FINACEA FOAM safely and effectively. See full prescribing information for FINACEA FOAM.FINACEA (azelaic acid) Foam, 15% for topical useInitial U.S. Approval: 2015prescriptionHuman PrescriptionBayer Healthcare Pharmaceuticals Inc.MANUFACTURE2015-07-293504190829

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