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FDA Drug Approval, N010401, MYSOLINE
FDA Drug Approval, N010401, MYSOLINE
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NDA: 010401
Company: FHTA
Drug Name: MYSOLINE
Active Ingredients: PRIMIDONE
Strength: SUSPENSION;ORAL
Dosage Form/Route: Discontinued
Action Date: ORIG-1
Marketing Status: None
Submission Classification: STANDARD
Company: FHTA
Drug Name: MYSOLINE
Active Ingredients: PRIMIDONE
Strength: SUSPENSION;ORAL
Dosage Form/Route: Discontinued
Action Date: ORIG-1
Marketing Status: None
Submission Classification: STANDARD
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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