FDA.reportPublic FDA data

Application 210566

Type
NDA
Sponsor
MAYNE PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEXETTEHALOBETASOL PROPIONATEAEROSOL, FOAM;TOPICAL0.05%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
51862-604LEXETTEHalobetasol propionateMayne PharmaNDACurrent
51862-604LEXETTEHalobetasol propionateMayne PharmaNDACurrent
51862-604LEXETTEHalobetasol propionateMayne PharmaNDACurrent
51862-604LEXETTEHalobetasol propionateMayne PharmaNDACurrent
51862-606Halobetasol propionateHalobetasol propionateMayne PharmaNDACurrent
51862-606Halobetasol propionateHalobetasol propionateMayne PharmaNDACurrent
51862-606Halobetasol propionateHalobetasol propionateMayne PharmaNDACurrent
51862-606Halobetasol propionateHalobetasol propionateMayne PharmaNDACurrent
51862-606Halobetasol propionateHalobetasol propionateMayne PharmaNDACurrent
55337-606Halobetasol propionateHalobetasol propionatePharmasol CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71610SUPPL2022-07-20
71606SUPPL2022-07-20
68422SUPPL2021-08-19
68412SUPPL2021-08-19
62675SUPPL2020-04-24
62658SUPPL2020-04-24
58383SUPPL2019-04-24
56527ORIG2018-11-20
54355ORIG2018-05-29
54349ORIG2018-05-24