Regulations.gov document

Determination of Regulatory Review Period for Purposes of Patent Extension; Nuzyra Tablets…

Notice · FDA-2019-E-5267 · posted Dec 8, 2023

Key facts

Document ID FDA-2019-E-5267-0004
Title Determination of Regulatory Review Period for Purposes of Patent Extension; Nuzyra Tablets (New Drug Application 209816)
Document type Notice
Subtype Determinations
Agency FDA
Docket FDA-2019-E-5267
Posted Dec 8, 2023
Federal Register citation 88 FR 85643
FR document number 2023-26989
Comment period opens Dec 8, 2023
Comments due Feb 7, 2024
Effective date Dec 8, 2023

At a glance

  • 1–9 Pages
  • No Open for comment
  • None Public comments on this docket

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