FDA — authorised 26 April 1994
- Application: ANDA074209
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: CROMOLYN SODIUM
- Indication: SOLUTION — INHALATION
- Status: approved
🇺🇸 CROMOLYN SODIUM in United States
FDA authorised CROMOLYN SODIUM on 26 April 1994 · 2,389 US adverse-event reports
Marketing authorisations
FDA — authorised 29 February 1996
- Application: NDA020479
- Marketing authorisation holder: VIATRIS SPECIALTY
- Indication: Labeling
- Status: approved
FDA — authorised 16 June 1999
- Application: ANDA075282
- Marketing authorisation holder: SANDOZ
- Local brand name: CROMOLYN SODIUM
- Indication: SOLUTION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 30 September 1999
- Application: ANDA075175
- Marketing authorisation holder: ROXANE
- Local brand name: CROMOLYN SODIUM
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 18 January 2000
- Application: ANDA075271
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: CROMOLYN SODIUM
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 21 December 2000
- Application: ANDA075585
- Marketing authorisation holder: BAUSCH
- Local brand name: CROMOLYN SODIUM
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 3 July 2001
- Application: ANDA075702
- Marketing authorisation holder: BAUSCH AND LOMB
- Status: approved
FDA — authorised 17 June 2005
- Application: ANDA076469
- Marketing authorisation holder: WATSON LABS
- Local brand name: CROMOLYN SODIUM
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 7 September 2007
- Application: ANDA077976
- Marketing authorisation holder: HH AND P
- Local brand name: CROMOLYN SODIUM
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA — authorised 27 October 2011
- Application: ANDA202583
- Marketing authorisation holder: RISING
- Local brand name: CROMOLYN SODIUM
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA — authorised 4 April 2013
- Application: ANDA202745
- Marketing authorisation holder: MICRO LABS LTD INDIA
- Indication: Labeling
- Status: approved
FDA — authorised 16 October 2017
- Application: ANDA209264
- Marketing authorisation holder: AILEX PHARMS LLC
- Status: approved
FDA — authorised 16 October 2017
- Application: ANDA209453
- Marketing authorisation holder: AILEX PHARMS LLC
- Local brand name: CROMOLYN SODIUM
- Indication: SOLUTION — INHALATION
- Status: approved
FDA — authorised 29 April 2022
- Application: ANDA213658
- Marketing authorisation holder: MICRO LABS
- Local brand name: CROMOLYN SODIUM
- Indication: SOLUTION — INHALATION
- 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.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 2,389
Most-reported reactions
- Treatment Failure — 1,006 reports (42.11%)
- Drug Ineffective — 308 reports (12.89%)
- Fatigue — 166 reports (6.95%)
- Nausea — 157 reports (6.57%)
- Headache — 150 reports (6.28%)
- Diarrhoea — 133 reports (5.57%)
- Urticaria — 132 reports (5.53%)
- Off Label Use — 120 reports (5.02%)
- Malaise — 109 reports (4.56%)
- Hypersensitivity — 108 reports (4.52%)
CROMOLYN SODIUM in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is CROMOLYN SODIUM approved in United States?
Yes. FDA authorised it on 26 April 1994; FDA authorised it on 29 February 1996; FDA authorised it on 16 June 1999.
Who is the marketing authorisation holder for CROMOLYN SODIUM in United States?
EUGIA PHARMA holds the US marketing authorisation.