← FDA DRUG APPROVALS

FDA BLA · BLA761127

DAXXIFY

botulinum toxin type a

Sponsor: REVANCE THERAPEUTICS, INC.

APPLICATION
BLA761127
TYPE
BLA
ORIGINAL APPROVAL
2022-09-07
LATEST ACTION
2023-08-11
ROUTE
INTRAMUSCULAR, INTRAMUSCULAR, SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

DAXXIFYPrescription
DAXIBOTULINUMTOXINA-LANM 0.1ML · INJECTABLE · INTRAMUSCULAR, SUBCUTANEOUS

Approval history

2023-08-11Efficacy · Supplement 2 · standard — Letter ↗AP
2022-09-07Type 1 - New Molecular Entity · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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