brimonidine Topical Gel

Brand(s)
Mirvaso
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Galderma Laboratories, L.P. (2015-11-02)
Oldest Current Product
2013-08-23
License(s)
NDA
RxNORM
TOPICAL GEL\BRIMONIDINE
FDAOB
TOPICAL\GEL\BRIMONIDINE TARTRATE
SPL Active
TOPICAL\GEL\BRIMONIDINE TARTRATE
SPL Moiety
TOPICAL\GEL\BRIMONIDINE

product(s) by strength(s)

brimonidine 0.0033 mg/mg topical gel

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1002995980MirvasoNDAGalderma Laboratories, L.P.2013-08-23BRIMONIDINE TARTRATETOPICALGELNDA204708f6a4353f-ae69-4214-901f-e5d42a6fbde7

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA204708MIRVASOGALDERMA LABORATORIES LP2013-08-23p8513249, TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA, SUBSTANCE
p8859551, TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
p7439241, TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
p8513247, TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA, SUBSTANCE
p8163725, SUBSTANCE
p8410102, TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
p8426410, TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
p8053427, TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA, SUBSTANCE
p8231885, SUBSTANCE
NEW DOSAGE FORM [2016-08-23]NDA204708_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA204708_001RXBRIMONIDINE TARTRATE (EQ 0.33% BASE)TOPICALGELTrue2013-08-23MIRVASO

patent(s)

#idexpiration dateapplication(s)
1p7439241 (view patent)2025-08-25NDA204708
2p8053427 (view patent)2031-06-13NDA204708
3p8163725 (view patent)2031-06-13NDA204708
4p8231885 (view patent)2025-05-24NDA204708
5p8410102 (view patent)2025-05-24NDA204708
6p8426410 (view patent)2025-05-24NDA204708
7p8513247 (view patent)2031-03-25NDA204708
8p8513249 (view patent)2031-03-25NDA204708
9p8859551 (view patent)2024-05-25NDA204708

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1f6a4353f-ae69-4214-901f-e5d42a6fbde7 (view SPL)These highlights do not include all the information needed to use MIRVASO safely and effectively. See full prescribing information for MIRVASO.MIRVASO (brimonidine) topical gel, for topical use Initial U.S. Approval: 1996prescriptionHuman PrescriptionGalderma Laboratories, L.P.manufacture2015-11-026002995980

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