Persistent Pulmonary Hypertension of the Newborn

• FDA approval · 2023-07-27
  FDA Approved: ULSPIRA — Original Application (Airgas Therapeutics, LLC)

  The FDA approved ULSPIRA (nitric oxide) through an original application (ANDA203144) by Airgas Therapeutics, LLC, establishing it as an inha…

• FDA approval · 2019-12-20
  FDA Approved: GENOSYL — Original Application (VERO BIOTECH, INC.)

  FDA approved GENOSYL (nitric oxide) from Vero Biotech, Inc., an inhaled nitric oxide therapy for term and near-term neonates with hypoxic re…

• FDA approval · 2019-02-13
  FDA Approved: INOMAX — Supplemental Application (INO Therapeutics LLC)

  The FDA approved a supplemental application for INOMAX (nitric oxide) submitted by INO Therapeutics LLC.

• FDA approval · 2014-02-28
  FDA Approved: INOMAX — Supplemental Application (INO Therapeutics LLC)

  The FDA approved a supplemental application for INOMAX (nitric oxide) from INO Therapeutics LLC, updating the product's labeling and/or indi…

• FDA approval · 2013-03-04
  FDA Approved: INOMAX — Supplemental Application (INO Therapeutics LLC)

  The FDA approved a supplemental application for INOMAX (nitric oxide) from INO Therapeutics LLC.

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• FDA approval · 2009-08-26
  FDA Approved: INOMAX — Supplemental Application (INO Therapeutics LLC)

  FDA approved a supplemental application for INOMAX (nitric oxide) from INO Therapeutics LLC. The approval updates the existing NDA for INOMA…

• FDA approval · 2007-12-04
  FDA Approved: INOMAX — Supplemental Application (INO Therapeutics LLC)

  The FDA approved a supplemental application for INOMAX (nitric oxide) from INO Therapeutics LLC, resulting in updated labeling for this inha…