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FDA Drug/Biologics Approval BLA 761044, USTEKINUMAB
FDA Drug/Biologics Approval BLA 761044, USTEKINUMAB
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BLA 761044
Company: JANSSEN BIOTECH
Drug Name: STELARA
Active Ingredients: USTEKINUMAB
Strength: 130MG/26ML
Dosage Form/Route: INJECTABLE;INJECTION
Action Date: 09/23/2016
Marketing Status: Prescription
Submission Classification: ORIG-1
Company: JANSSEN BIOTECH
Drug Name: STELARA
Active Ingredients: USTEKINUMAB
Strength: 130MG/26ML
Dosage Form/Route: INJECTABLE;INJECTION
Action Date: 09/23/2016
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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