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FDA BLA · BLA103846

MYOBLOC

rimabotulinumtoxinb

Sponsor: ELAN PHARM

APPLICATION
BLA103846
TYPE
BLA
ORIGINAL APPROVAL
2000-12-08
LATEST ACTION
2021-03-10
ROUTE
INTRAMUSCULAR
DOSAGE FORM
VIAL
MARKETING STATUS
Prescription

Products

MYOBLOCPrescription
Botulinum Toxin Type B 5000IU/VIAL · VIAL

Approval history

2021-03-10Labeling · Supplement 5195 · standard — Label ↗AP
2019-08-20Efficacy · Supplement 5190 · standard — Letter ↗AP
2012-06-13Labeling · Supplement 5156 · standard — Letter ↗AP
2009-07-31Labeling · Supplement 5120 · standard — Label ↗AP
2000-12-08Type 1 - New Molecular Entity · Original · standard — Review ↗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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