FDA.reportPublic FDA data

Application 021307

Type
NDA
Sponsor
BAYER HEALTHCARE LLC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11523-0082Lotrimin UltraButenafine hydrochlorideBayer Healthcare LLC.NDACurrent
11523-0082Lotrimin UltraButenafine hydrochlorideBayer Healthcare LLC.NDACurrent
11523-0082Lotrimin UltraButenafine hydrochlorideBayer Healthcare LLC.NDACurrent
11523-4338Lotrimin UltraButenafine hydrochlorideBayer Healthcare LLC.NDACurrent
11523-4338Lotrimin UltraButenafine hydrochlorideBayer Healthcare LLC.NDACurrent
11523-4338Lotrimin UltraButenafine hydrochlorideBayer Healthcare LLC.NDACurrent
11523-4338Lotrimin UltraButenafine hydrochlorideBayer Healthcare LLC.NDACurrent
11523-4338Lotrimin UltraButenafine hydrochlorideBayer Healthcare LLC.NDACurrent
11523-4339Lotrimin UltraButenafine hydrochlorideBayer Healthcare LLC.NDACurrent
11523-4339Lotrimin UltraButenafine hydrochlorideBayer Healthcare LLC.NDACurrent
11523-4339Lotrimin UltraButenafine hydrochlorideBayer Healthcare LLC.NDACurrent
11523-7154Lotrimin UltraButenafine HydrochlorideBayer HealthCare LLC.NDACurrent
11523-7155Lotrimin Ultra Jock ItchButenafine HydrochlorideBayer HealthCare LLC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79040SUPPL 2024-07-11
79039SUPPL 2024-07-11
78194SUPPL 2024-04-22
78186SUPPL 2024-04-22
77186SUPPL 2024-01-04
77178SUPPL 2024-01-04
75332SUPPL 2023-08-31
75322SUPPL 2023-08-30
69536SUPPL2021-12-13
69039SUPPL2021-10-20
65702SUPPL2020-12-23
65700SUPPL2020-12-23
15161SUPPL2015-12-22
4995SUPPL2015-12-22
27445SUPPL2014-12-18
4994SUPPL2012-05-04
27444SUPPL2011-04-04
4993SUPPL2006-04-07
21588ORIG2002-03-26
36631ORIG2001-12-07
4992ORIG2001-12-07