FDA.reportPublic FDA data

Application 020934

Type
NDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LUXIQBETAMETHASONE VALERATEAEROSOL, FOAM;TOPICAL0.12%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-8180Betamethasone ValerateBetamethasone ValerateMylan Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
0378-8187LuxiqBetamethasone ValerateMylan Pharmaceuticals Inc.NDACurrent
40076-021LuxiqBetamethasone ValeratePrestium Pharma, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
49010SUPPL2017-07-18
3787SUPPL2006-07-13
35664SUPPL2004-01-02
26228SUPPL2004-01-02
26227SUPPL2003-12-04
3785SUPPL2002-10-09
3786SUPPL2002-10-08
3784SUPPL2002-02-28
21283ORIG1999-06-16
35663ORIG1999-02-28
26226ORIG1999-02-28