FDA Approved Package Insert for Gynorest (dydrogesterone tablets) – NDA 17388, approved October 31, 1978.

FDA Approved Package Insert for Gynorest (dydrogesterone tablets) – NDA 17388, approved October 31, 1978.

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Original Request: Requesting a copy of the approved PACKAGE INSERT for Gynorest(dydrogesterone tablets) NDA 17388 which according to FRN FDA-2016-P-2675 Gynorest was approved on October 31, 1978.
  • 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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