FDA.reportPublic FDA data

Application 022563

Type
NDA
Sponsor
MAYNE PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SORILUXCALCIPOTRIENEAEROSOL, FOAM;TOPICAL0.005%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51862-376SORILUXcalcipotrieneMayne PharmaNDACurrent
51862-376SORILUXcalcipotrieneMayne PharmaNDACurrent
51862-376SORILUXcalcipotrieneMayne PharmaNDACurrent
51862-376SORILUXcalcipotrieneMayne PharmaNDACurrent
51862-512calcipotrienecalcipotrieneMayne PharmaNDACurrent
73308-357CALCIPOTRIENEcalcipotrieneAyuraxNDACurrent
73352-886Calcipotriene 0.005% 60 gram FoamCalcipotriene 0.005% 60 gram FoamTrifluent Pharma LLCNDACurrent
73352-886Calcipotriene 0.005% 60 gram FoamCalcipotriene 0.005% 60 gram FoamTrifluent Pharma LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60796SUPPL2019-11-08
60795SUPPL2019-11-08
58591SUPPL2019-05-07
29861SUPPL2012-10-02
17711SUPPL2012-09-28
42558ORIG2011-05-03
24341ORIG2011-05-03
7534SUPPL2011-04-25
17710SUPPL2011-04-22
7533ORIG2010-10-13
38841ORIG2010-10-12
62875SUPPL1900-01-01
62874SUPPL1900-01-01
62873SUPPL1900-01-01