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NitroMist Approval History

  • FDA approved: Yes (First approved November 2nd, 2006)
  • Brand name: NitroMist
  • Generic name: nitroglycerin
  • Dosage form: Lingual Aerosol
  • Company: NovaDel Pharma
  • Treatment for: Angina

NitroMist is an oral spray formulation of nitroglycerin indicated for acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.

Development History and FDA Approval Process for NitroMist

Nov  2, 2006Approval NitroMist NovaDel Pharma - Treatment for Angina Pectoris
May 26, 2006FDA Accepts Submission for NitroMist as Complete Response
Jun  2, 2005NovaDel Pharma Receives Approvable Letter from the FDA for NitroMist - nitroglycerin lingual aerosol
Sep 29, 2004NovaDel NDA for Nitroglycerin Lingual Spray is Accepted for Review by FDA
Jun 21, 2004NovaDel Pharma files for US FDA approval of Nitroglycerin Lingual Spray, its first product

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