FDA Tentative Approval – Estradiol Valerate & Dienogest Tablets (ANDA 202999, DR REDDYS LABS SA)

FDA Tentative Approval – Estradiol Valerate & Dienogest Tablets (ANDA 202999, DR REDDYS LABS SA)

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Original Request Contents: Tentative Approval letter for Estradiol Valerate and Dienogest Tablets, ANDA 202999, Applicant: DR REDDYS LABS SA (transferred from Mayne Pharma)
  • 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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