← FDA DRUG APPROVALS

FDA BLA · BLA103000

BOTOX COSMETIC

onabotulinumtoxina

Sponsor: ALLERGAN

APPLICATION
BLA103000
TYPE
BLA
ORIGINAL APPROVAL
1991-12-09
LATEST ACTION
2024-10-18
ROUTE
INTRAMUSCULAR, SINGLE-USE
DOSAGE FORM
VIAL
MARKETING STATUS
Prescription

Products

BOTOX COSMETICPrescription
OnabotulinumtoxinA 100 UNITS/VIAL · VIAL · SINGLE-USE
BOTOXPrescription
OnabotulinumtoxinA 200 UNITS/VIAL · VIAL · SINGLE-USE
BOTOXPrescription
OnabotulinumtoxinA 50 UNITS/VIAL · VIAL · SINGLE-USE
BOTOX COSMETICPrescription
OnabotulinumtoxinA 50 UNITS/VIAL · VIAL · SINGLE-USE
BOTOXPrescription
OnabotulinumtoxinA 100 UNITS/VIAL · VIAL · SINGLE-USE

Approval history

2024-10-18Labeling · Supplement 5326 · standard — Letter ↗AP
2024-10-18Labeling · Supplement 5316 · standard — Label ↗AP
2024-10-18Labeling · Supplement 5319 · standard — Label ↗AP
2024-10-18Efficacy · Supplement 5331 · standard — Medication Guide ↗AP
2024-10-18Labeling · Supplement 5323 · standard — Label ↗AP
2023-08-11Efficacy · Supplement 5325 · standard — Letter ↗AP
2023-08-10Labeling · Supplement 5327 · standard — Letter ↗AP
2022-08-22Labeling · Supplement 5322 · standard — Label ↗AP
2021-07-28Efficacy · Supplement 5320 · standard — Label ↗AP
2021-02-09Efficacy · Supplement 5318 · standard — Label ↗AP
2020-09-13Labeling · Supplement 5317 · standard — Letter ↗AP
2020-07-08Efficacy · Supplement 5315 · standard — Letter ↗AP
2019-10-18Efficacy · Supplement 5310 · standard — Label ↗AP
2019-06-20Efficacy · Supplement 5309 · priority — Label ↗AP
2018-09-12Efficacy · Supplement 5308 · standard — Letter ↗AP
2018-05-16Labeling · Supplement 5306 · standard — Label ↗AP
2018-05-15Labeling · Supplement 5307 · standard — Label ↗AP
2017-10-02Efficacy · Supplement 5303 · standard — Label ↗AP
2017-04-20Labeling · Supplement 5302 · standard — Label ↗AP
2017-04-04Efficacy · Supplement 5298 · standard — Label ↗AP
2017-04-04Efficacy · Supplement 5296 · standard — Label ↗AP
2017-04-04Efficacy · Supplement 5297 · standard — Label ↗AP
2016-02-04Efficacy · Supplement 5294 · standard — Letter ↗AP
2016-01-21Efficacy · Supplement 5252 · standard — Label ↗AP
2015-08-11Labeling · Supplement 5292 · standard — Label ↗AP
2015-08-05Labeling · Supplement 5244 · standard — Label ↗AP
2015-04-17Efficacy · Supplement 5282 · standard — Label ↗AP
2014-05-07Labeling · Supplement 5280 · standard — Letter ↗AP
2013-09-11Efficacy · Supplement 5260 · standard — Label ↗AP
2013-01-18Efficacy · Supplement 5251 · standard — Label ↗AP
2012-11-09Labeling · Supplement 5253 · standard — Letter ↗AP
2012-07-16Labeling · Supplement 5256 · standard — Letter ↗AP
2011-08-24Efficacy · Supplement 5232 · standard — Label ↗AP
2011-06-23Supplement · Supplement 5236 — Label ↗AP
2010-10-15Efficacy · Supplement 5215 · standard — Review ↗AP
2010-06-03Supplement · Supplement 5219AP
2010-03-26Efficacy · Supplement 5129 · standardAP
2010-03-26Labeling · Supplement 5120 · standardAP
2010-03-09Efficacy · Supplement 5189 · priority — Review ↗AP
2009-08-21Supplement · Supplement 5197AP
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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