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FDA Approval Package – NDA 020392 for CYSTAGON Capsules (50 mg & 150 mg, Mylan Pharmaceuticals Inc.)
FDA Approval Package – NDA 020392 for CYSTAGON Capsules (50 mg & 150 mg, Mylan Pharmaceuticals Inc.)
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Original Request Contents: Approval Package for NDA 020392, CYSTAGON (cysteamine bitartrate) Capsules 50 mg and 150 mg (NDA holder: Mylan Pharmaceuticals Inc.) – includes Product Quality Review, Clinical Pharmacology/Biopharmaceutics, Clinical, Non-Clinical, Proprietary Name, Other, Statistical, Summary Reviews, Administrative/correspondence, and Approval letter
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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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