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FDA Drug/Biologics Approval BLA 103000 S-5320, OnabotulinumtoxinA
FDA Drug/Biologics Approval BLA 103000 S-5320, OnabotulinumtoxinA
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BLA 103000 S-5320
Company: ALLERGAN
Drug Name: BOTOX COSMETIC
Active Ingredients: OnabotulinumtoxinA
Strength: 100 UNITS/VIAL
Dosage Form/Route: VIAL; SINGLE-USE
Action Date: 12/09/1991
Marketing Status: Prescription
Submission Classification: ORIG-1
Company: ALLERGAN
Drug Name: BOTOX COSMETIC
Active Ingredients: OnabotulinumtoxinA
Strength: 100 UNITS/VIAL
Dosage Form/Route: VIAL; SINGLE-USE
Action Date: 12/09/1991
Marketing Status: Prescription
Submission Classification: ORIG-1
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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