🇺🇸 RIMANTADINE HYDROCHLORIDE in United States

FDA authorised RIMANTADINE HYDROCHLORIDE on 17 September 1993 · 23 US adverse-event reports

Marketing authorisations

FDA — authorised 17 September 1993

  • Application: NDA019649
  • Marketing authorisation holder: SUN PHARM INDS INC
  • Local brand name: FLUMADINE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 17 September 1993

  • Application: NDA019650
  • Marketing authorisation holder: FOREST LABS
  • Local brand name: FLUMADINE
  • Indication: SYRUP — ORAL
  • Status: approved

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FDA — authorised 2 November 2001

  • Application: ANDA075916
  • Marketing authorisation holder: IMPAX LABS INC
  • Local brand name: RIMANTADINE HYDROCHLORIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 30 August 2002

  • Application: ANDA076132
  • Marketing authorisation holder: IMPAX LABS
  • Local brand name: RIMANTADINE HYDROCHLORIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA — authorised 14 January 2003

  • Application: ANDA076375
  • Marketing authorisation holder: CHARTWELL RX
  • Local brand name: RIMANTADINE HYDROCHLORIDE
  • Indication: TABLET — ORAL
  • Status: approved

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FDA

  • Status: approved

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 — 4 reports (17.39%)
  2. Malaise — 3 reports (13.04%)
  3. Convulsion — 2 reports (8.7%)
  4. Drug Resistance — 2 reports (8.7%)
  5. Dyspnoea — 2 reports (8.7%)
  6. Febrile Neutropenia — 2 reports (8.7%)
  7. Hyperhidrosis — 2 reports (8.7%)
  8. Hyperkalaemia — 2 reports (8.7%)
  9. Myocardial Infarction — 2 reports (8.7%)
  10. Pneumocystis Jiroveci Pneumonia — 2 reports (8.7%)

Source database →

RIMANTADINE HYDROCHLORIDE in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is RIMANTADINE HYDROCHLORIDE approved in United States?

Yes. FDA authorised it on 17 September 1993; FDA authorised it on 17 September 1993; FDA authorised it on 2 November 2001.

Who is the marketing authorisation holder for RIMANTADINE HYDROCHLORIDE in United States?

SUN PHARM INDS INC holds the US marketing authorisation.