🇺🇸 sublingual nitroglycerine in United States

FDA authorised sublingual nitroglycerine on 31 October 1985 · 10 US adverse-event reports

Marketing authorisation

FDA — authorised 31 October 1985

  • Application: NDA018705
  • Marketing authorisation holder: POHL BOSKAMP
  • Local brand name: NITROLINGUAL
  • Indication: AEROSOL — SUBLINGUAL
  • Status: approved

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Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Blood Potassium Increased — 1 report (10%)
  2. Decreased Appetite — 1 report (10%)
  3. Fatigue — 1 report (10%)
  4. Headache — 1 report (10%)
  5. Hepatitis Cholestatic — 1 report (10%)
  6. Left Atrial Dilatation — 1 report (10%)
  7. Liver Function Test Abnormal — 1 report (10%)
  8. Myocardial Ischaemia — 1 report (10%)
  9. Pulmonary Valve Incompetence — 1 report (10%)
  10. Pyrexia — 1 report (10%)

Source database →

Other Cardiovascular approved in United States

Frequently asked questions

Is sublingual nitroglycerine approved in United States?

Yes. FDA authorised it on 31 October 1985.

Who is the marketing authorisation holder for sublingual nitroglycerine in United States?

POHL BOSKAMP holds the US marketing authorisation.