← FDA DRUG APPROVALS

FDA BLA · BLA125274

DYSPORT

botulinum toxin type a

Sponsor: IPSEN BIOPHARM LTD

APPLICATION
BLA125274
TYPE
BLA
ORIGINAL APPROVAL
2009-04-29
LATEST ACTION
2023-09-21
ROUTE
INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

DYSPORTPrescription
abobotulinumtoxinA 300 UNITS/VIAL · INJECTABLE · INJECTION
DYSPORTPrescription
abobotulinumtoxinA 500 UNITS/VIAL · INJECTABLE · INJECTION

Approval history

2023-09-21Labeling · Supplement 125 · standard — Letter ↗AP
2023-01-12Efficacy · Supplement 123 · standard — Label ↗AP
2020-07-08Efficacy · Supplement 118 · standard — Label ↗AP
2019-09-25Efficacy · Supplement 115 · priority — Letter ↗AP
2018-11-05Labeling · Supplement 112 · standard — Label ↗AP
2017-06-14Efficacy · Supplement 109 · standard — Label ↗AP
2016-12-09Efficacy · Supplement 107 · standard — Label ↗AP
2016-07-29Efficacy · Supplement 105 — Pediatric CDTL Review ↗AP
2015-07-15Efficacy · Supplement 102 — Letter ↗AP
2012-05-22Labeling · Supplement 52 · standard — Label ↗AP
2010-09-27Labeling · Supplement 14 · standardAP
2009-04-29Efficacy · Supplement 1 · standard — Review ↗AP
2009-04-29Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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