FDA — authorised 29 February 1996
- Application: NDA020479
- Marketing authorisation holder: VIATRIS SPECIALTY
- Local brand name: GASTROCROM
- Indication: CONCENTRATE — ORAL
- Status: approved
🇺🇸 oral cromolyn sodium in United States
FDA authorised oral cromolyn sodium on 29 February 1996
Marketing authorisations
FDA
- Status: approved
FDA
- Application: NDA019188
- Marketing authorisation holder: UCB INC
- Local brand name: GASTROCROM
- Indication: CAPSULE — ORAL
- Status: approved
oral cromolyn sodium 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 oral cromolyn sodium approved in United States?
Yes. FDA authorised it on 29 February 1996; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for oral cromolyn sodium in United States?
VIATRIS SPECIALTY holds the US marketing authorisation.