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FDA Drug Approval, N208289, AKOVAZ
FDA Drug Approval, N208289, AKOVAZ
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NDA: 208289
Company: EXELA PHARMA
Drug Name: AKOVAZ
Active Ingredients: EPHEDRINE SULFATE
Strength: 25MG/5ML (5MG/ML)
Dosage Form/Route: SOLUTION;INTRAVENOUS
Action Date: 04/29/2016
Marketing Status: Prescription
Submission Classification: Type 7 - Drug Already Marketed without Approved NDA
Company: EXELA PHARMA
Drug Name: AKOVAZ
Active Ingredients: EPHEDRINE SULFATE
Strength: 25MG/5ML (5MG/ML)
Dosage Form/Route: SOLUTION;INTRAVENOUS
Action Date: 04/29/2016
Marketing Status: Prescription
Submission Classification: Type 7 - Drug Already Marketed without Approved NDA
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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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