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FDA Drug Approval, N008372, ACTHAR GEL (AUTOINJECTOR)
FDA Drug Approval, N008372, ACTHAR GEL (AUTOINJECTOR)
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NDA: 008372
Company: MALLINCKRODT ARD
Drug Name: ACTHAR GEL (AUTOINJECTOR)
Active Ingredients: CORTICOTROPIN
Strength: INJECTABLE;INJECTION
Dosage Form/Route: Prescription
Action Date: ORIG-1
Marketing Status: None
Submission Classification: STANDARD; Orphan
Company: MALLINCKRODT ARD
Drug Name: ACTHAR GEL (AUTOINJECTOR)
Active Ingredients: CORTICOTROPIN
Strength: INJECTABLE;INJECTION
Dosage Form/Route: Prescription
Action Date: ORIG-1
Marketing Status: None
Submission Classification: STANDARD; Orphan
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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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