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FDA Drug/Biologics Approval BLA 125514 S-097, PEMBROLIZUMAB
FDA Drug/Biologics Approval BLA 125514 S-097, PEMBROLIZUMAB
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BLA 125514 S-097
Company: MERCK SHARP DOHME
Drug Name: KEYTRUDA
Active Ingredients: PEMBROLIZUMAB
Strength: 100MG/4ML (25MG/ML)
Dosage Form/Route: SOLUTION;INTRAVENOUS
Action Date: 09/04/2014
Marketing Status: Prescription
Submission Classification: ORIG-1
Company: MERCK SHARP DOHME
Drug Name: KEYTRUDA
Active Ingredients: PEMBROLIZUMAB
Strength: 100MG/4ML (25MG/ML)
Dosage Form/Route: SOLUTION;INTRAVENOUS
Action Date: 09/04/2014
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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