🇺🇸 Naridrin in United States

FDA authorised Naridrin on 7 June 1971 · 24 US adverse-event reports

Marketing authorisations

FDA — authorised 7 June 1971

  • Application: ANDA080235
  • Marketing authorisation holder: NOVARTIS
  • Local brand name: VASOCON
  • Indication: SOLUTION/DROPS — OPHTHALMIC
  • Status: approved

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FDA — authorised 24 March 1972

  • Application: ANDA080248
  • Marketing authorisation holder: ALLERGAN
  • Local brand name: ALBALON
  • Indication: SOLUTION/DROPS — OPHTHALMIC
  • Status: approved

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FDA — authorised 22 August 1974

  • Application: ANDA083590
  • Marketing authorisation holder: RISING
  • Local brand name: NAPHAZOLINE HYDROCHLORIDE
  • Indication: SOLUTION/DROPS — OPHTHALMIC
  • Status: approved

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FDA — authorised 1 December 1981

  • Application: ANDA087506
  • Marketing authorisation holder: BAUSCH AND LOMB
  • Local brand name: OPCON
  • Indication: SOLUTION/DROPS — OPHTHALMIC
  • Status: approved

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FDA — authorised 25 May 1994

  • Application: ANDA040073
  • Marketing authorisation holder: BAUSCH AND LOMB
  • Local brand name: NAFAZAIR
  • Indication: SOLUTION/DROPS — OPHTHALMIC
  • Status: approved

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FDA — authorised 8 June 1994

  • Application: NDA020226
  • Marketing authorisation holder: ALCON
  • Local brand name: NAPHCON-A
  • Indication: SOLUTION/DROPS — OPHTHALMIC
  • Status: approved

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FDA — authorised 24 January 2013

  • Application: ANDA202795
  • Marketing authorisation holder: RISING
  • Local brand name: NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE
  • Indication: SOLUTION/DROPS — OPHTHALMIC
  • Status: approved

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FDA

  • Application: ANDA088101
  • Marketing authorisation holder: PHARMAFAIR
  • Local brand name: NAFAZAIR
  • Indication: SOLUTION/DROPS — OPHTHALMIC
  • 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. Drug Ineffective — 3 reports (12.5%)
  2. Malaise — 3 reports (12.5%)
  3. Pain — 3 reports (12.5%)
  4. Pyrexia — 3 reports (12.5%)
  5. Alopecia — 2 reports (8.33%)
  6. Diabetes Mellitus — 2 reports (8.33%)
  7. Dizziness — 2 reports (8.33%)
  8. Drug Dependence — 2 reports (8.33%)
  9. Dyspnoea — 2 reports (8.33%)
  10. Erythema — 2 reports (8.33%)

Source database →

Other Other approved in United States

Frequently asked questions

Is Naridrin approved in United States?

Yes. FDA authorised it on 7 June 1971; FDA authorised it on 24 March 1972; FDA authorised it on 22 August 1974.

Who is the marketing authorisation holder for Naridrin in United States?

NOVARTIS holds the US marketing authorisation.