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FDA Approval Letters – ANDA 214112 Tentative (1/11/2023), ANDA 211107 Effective (8/05/2024), ANDA 211198 Effective (4/18/2023) for Macitentan
FDA Approval Letters – ANDA 214112 Tentative (1/11/2023), ANDA 211107 Effective (8/05/2024), ANDA 211198 Effective (4/18/2023) for Macitentan
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Original Request Contents: Request copies of the 1/11/2023 Tentative Approval letter for ANDA 214112 for Macitentan; the 8/05/2024 Effective Approval letter for ANDA 211107 for Macitentan; and the 4/18/2023 Effective Approval letter for ANDA 211198 for Macitentan.
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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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