Regulations.gov document

Determination of Regulatory Review Period for Purposes of Patent Extension; BRIVIACT…

Notice · FDA-2016-E-2525 · posted Dec 12, 2019

Key facts

Document ID FDA-2016-E-2525-0006
Title Determination of Regulatory Review Period for Purposes of Patent Extension; BRIVIACT INJECTION New Drug Application 205837
Document type Notice
Subtype Determinations
Agency FDA
Docket FDA-2016-E-2525
Posted Dec 12, 2019
Federal Register citation 84 FR 67945
FR document number 2019-26812
Comment period opens Dec 12, 2019
Comments due Feb 11, 2020
Effective date Dec 12, 2019

At a glance

  • 1–9 Pages
  • No Open for comment
  • 1–9 Public comments on this docket

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