FDA.reportPublic FDA data

Application 022013

Type
NDA
Sponsor
MYLAN

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-8055Clobetasol PropionateClobetasol PropionateMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8055Clobetasol PropionateClobetasol PropionateMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8147OLUX-Eclobetasol propionateMylan Pharmaceuticals Inc.NDACurrent
0378-8147OLUX-Eclobetasol propionateMylan Pharmaceuticals Inc.NDACurrent
0378-8147OLUX-Eclobetasol propionateMylan Pharmaceuticals IncNDACurrent
40076-101OLUX-Eclobetasol propionatePrestium Pharma, Inc.NDACurrent
40076-101OLUX-Eclobetasol propionatePrestium Pharma, Inc.NDACurrent
40085-893Clobetasol Propionate Emulsionclobetasol propionateRenaissance Pharma, Inc.NDA AUTHORIZED GENERICCurrent
40085-893Clobetasol Propionate Emulsionclobetasol propionateRenaissance Pharma, Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
54243SUPPL2018-05-17
54213SUPPL2018-05-16
16770SUPPL2013-04-30
29077SUPPL2013-04-24
6688SUPPL2010-11-18
38085SUPPL2010-11-12
21907ORIG2008-10-03
29076SUPPL2007-07-24
6687ORIG2007-01-25
16769ORIG2007-01-16