FDA.reportPublic FDA data

Application 761127

Type
BLA
Sponsor
REVANCE THERAPEUTICS, INC.

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761127DaxxifydaxibotulinumtoxinA-lanm351(a)Rx2026-09-01

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DAXXIFYdaxibotulinumtoixnA-lanmINJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS0.1MLNoNo

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DAXXIFYBOTULINUM TOXIN TYPE ARevance Therapeutics, Inc.3aaa6e14-a3f7-4fb2-b9f9-d3a9c3ae1f742026-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761127
ndc (product): 72960-112

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 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
72960-112DAXXIFYbotulinum toxin type ARevance Therapeutics, Inc.BLACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75081SUPPL 2023-08-16
75080SUPPL 2023-08-16
75061SUPPL 2023-08-14
72258ORIG2022-10-06
72051ORIG2022-09-09
72050ORIG2022-09-09
72047ORIG2022-09-08