Methanol Poisoning

• FDA approval · 2023-07-06
  FDA Approved: FOMEPIZOLE — Original Application (Sagent Pharmaceuticals)

  FDA approved fomepizole under an original application from Sagent Pharmaceuticals, providing a generic antidote for methanol and ethylene gl…

• FDA approval · 2020-12-23
  FDA Approved: FOMEPIZOLE — Supplemental Application (Navinta LLC)

  FDA approved a supplemental application for fomepizole from Navinta LLC, providing a generic form of the antidote used to treat methanol and…

• FDA approval · 2020-12-23
  FDA Approved: FOMEPIZOLE — Supplemental Application (American Regent, Inc.)

  The FDA approved a supplemental application for Fomepizole from American Regent, Inc., effectively approving continued marketing and labelin…

• FDA approval · 2020-12-23
  FDA Approved: FOMEPIZOLE — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for fomepizole from Mylan Institutional LLC, authorizing continued marketing and labeling updates fo…

• FDA approval · 2015-03-18
  FDA Approved: FOMEPIZOLE — Supplemental Application (Navinta LLC)

  FDA approved a supplemental Abbreviated New Drug Application for fomepizole from Navinta LLC.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2008-03-06
  FDA Approved: FOMEPIZOLE — Original Application (Navinta LLC)

  FDA approved the original application for fomepizole from Navinta LLC, establishing a generic antidote for methanol and ethylene glycol pois…

• FDA approval · 2008-03-03
  FDA Approved: FOMEPIZOLE — Original Application (Mylan Institutional LLC)

  The FDA approved a generic fomepizole product through an original application (ANDA 078639) submitted by Mylan Institutional LLC. The approv…

• FDA approval · 2007-12-14
  FDA Approved: FOMEPIZOLE — Original Application (American Regent, Inc.)

  FDA approves American Regent, Inc.'s original application for fomepizole, the antidote used to treat methanol and ethylene glycol poisoning.