Application 020524

Type
NDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MENTAXBUTENAFINE HYDROCHLORIDECREAM;TOPICAL1%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-6151MENTAXbutenafine hydrochlorideMylan Pharmaceuticals Inc.NDACurrent
0378-6151MENTAXbutenafine hydrochlorideMylan Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57657ORIG2019-02-15
20702SUPPL2001-11-20
34769SUPPL2001-06-06
2663SUPPL2001-06-06