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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021307-001LOTRIMIN ULTRABUTENAFINE HYDROCHLORIDE1%CREAM / TOPICALRLD, RS2001-12-07

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N021307-001LOTRIMIN ULTRA1%CREAM / TOPICALRLD, RS2001-12-07a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lotrimin Ultra Jock ItchBUTENAFINE HYDROCHLORIDEBayer Healthcare LLC.9dfa08fb-0913-4326-b1eb-1425df6a2c822025-12-05WarningsExact identifier
application applno (NDA): 021307
application number: NDA021307
ndc (product): 11523-4339
Lotrimin Ultra Athletes FootBUTENAFINE HYDROCHLORIDEBayer Healthcare LLC.e258c4ac-53ef-4a99-b732-4985f890b9382025-12-05WarningsExact identifier
application applno (NDA): 021307
application number: NDA021307
ndc (product): 11523-4338
Lotrimin UltraBUTENAFINE HYDROCHLORIDEBayer Healthcare LLC.d11dfdf6-9b36-03bc-e053-2995a90a0bc32025-12-04WarningsExact identifier
application applno (NDA): 021307
application number: NDA021307
ndc (product): 11523-0082
Lotrimin Ultra RingwormBUTENAFINE HYDROCHLORIDEBayer Healthcare LLC.1b438ca7-fd5f-62cb-e063-6294a90ab3a62025-12-04WarningsExact identifier
application applno (NDA): 021307
application number: NDA021307

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 13 matching rows.

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