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FDA Drug/Biologics Approval BLA 103362 S-5240, SARGRAMOSTIM
FDA Drug/Biologics Approval BLA 103362 S-5240, SARGRAMOSTIM
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BLA 103362 S-5240
Company: BERLEX LABS
Drug Name: LEUKINE
Active Ingredients: SARGRAMOSTIM
Strength: 500UG/ML
Dosage Form/Route: VIAL
Action Date: 03/05/1991
Marketing Status: Prescription
Submission Classification: ORIG-1
Company: BERLEX LABS
Drug Name: LEUKINE
Active Ingredients: SARGRAMOSTIM
Strength: 500UG/ML
Dosage Form/Route: VIAL
Action Date: 03/05/1991
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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