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FDA Drug/Biologics Approval BLA 761139 S-021, FAM-TRASTUZUMAB DERUXTECAN-NXKI
FDA Drug/Biologics Approval BLA 761139 S-021, FAM-TRASTUZUMAB DERUXTECAN-NXKI
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BLA 761139 S-021
Company: DAIICHI SANKYO
Drug Name: ENHERTU
Active Ingredients: FAM-TRASTUZUMAB DERUXTECAN-NXKI
Strength: 100MG
Dosage Form/Route: INJECTABLE;INJECTION
Action Date: 12/20/2019
Marketing Status: Prescription
Submission Classification: ORIG-1
Company: DAIICHI SANKYO
Drug Name: ENHERTU
Active Ingredients: FAM-TRASTUZUMAB DERUXTECAN-NXKI
Strength: 100MG
Dosage Form/Route: INJECTABLE;INJECTION
Action Date: 12/20/2019
Marketing Status: Prescription
Submission Classification: ORIG-1
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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