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FDA Drug/Biologics Approval BLA 103792, TRASTUZUMAB
FDA Drug/Biologics Approval BLA 103792, TRASTUZUMAB
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BLA 103792
Company: GENENTECH
Drug Name: HERCEPTIN
Active Ingredients: TRASTUZUMAB
Strength: 21MG/ML
Dosage Form/Route: VIAL; INTRAVENOUS
Action Date: 09/25/1998
Marketing Status: Prescription
Submission Classification: ORIG-1
Company: GENENTECH
Drug Name: HERCEPTIN
Active Ingredients: TRASTUZUMAB
Strength: 21MG/ML
Dosage Form/Route: VIAL; INTRAVENOUS
Action Date: 09/25/1998
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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