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FDA Communications – Sponsor-FDA Discussions on Gepirone (Exxua, NDA 021164) Marketing Status
FDA Communications – Sponsor-FDA Discussions on Gepirone (Exxua, NDA 021164) Marketing Status
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Original Request Contents: Communications between sponsor and FDA regarding marketing status of gepirone (brand Exxua, NDA 021164) per 21 CFR 314.81(b)(2)(ii)(a) and 314.81(b)(3)(iv)
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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