🇺🇸 CROMOLYN in United States

FDA authorised CROMOLYN on 29 February 1996 · 2,988 US adverse-event reports

Marketing authorisations

FDA — authorised 29 February 1996

  • Application: NDA020479
  • Marketing authorisation holder: VIATRIS SPECIALTY
  • Status: supplemented

FDA — authorised 16 June 1999

  • Application: ANDA075282
  • Marketing authorisation holder: SANDOZ
  • Status: supplemented

FDA — authorised 18 January 2000

  • Application: ANDA075271
  • Marketing authorisation holder: TEVA PHARMS
  • Status: supplemented

FDA — authorised 4 April 2013

  • Application: ANDA202745
  • Marketing authorisation holder: MICRO LABS LTD INDIA
  • Status: approved

FDA — authorised 16 October 2017

  • Application: ANDA209264
  • Marketing authorisation holder: AILEX PHARMS LLC
  • Status: approved

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. Treatment Failure — 1,041 reports (34.84%)
  2. Drug Ineffective — 396 reports (13.25%)
  3. Fatigue — 250 reports (8.37%)
  4. Nausea — 228 reports (7.63%)
  5. Headache — 201 reports (6.73%)
  6. Off Label Use — 192 reports (6.43%)
  7. Diarrhoea — 182 reports (6.09%)
  8. Urticaria — 174 reports (5.82%)
  9. Dyspnoea — 164 reports (5.49%)
  10. Dizziness — 160 reports (5.35%)

Source database →

Frequently asked questions

Is CROMOLYN approved in United States?

Yes. FDA authorised it on 29 February 1996; FDA authorised it on 16 June 1999; FDA authorised it on 18 January 2000.

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

VIATRIS SPECIALTY holds the US marketing authorisation.