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FDA Drug/Biologics Approval BLA 125031 S-181, PEGFILGRASTIM
FDA Drug/Biologics Approval BLA 125031 S-181, PEGFILGRASTIM
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BLA 125031 S-181
Company: AMGEN
Drug Name: NEULASTA
Active Ingredients: PEGFILGRASTIM
Strength: 6MG/0.6ML
Dosage Form/Route: SYRINGE
Action Date: 01/31/2002
Marketing Status: Prescription
Submission Classification: ORIG-1
Company: AMGEN
Drug Name: NEULASTA
Active Ingredients: PEGFILGRASTIM
Strength: 6MG/0.6ML
Dosage Form/Route: SYRINGE
Action Date: 01/31/2002
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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