FDA
- Application: ANDA076748
- Marketing authorisation holder: DR REDDYS LABS INC
- Local brand name: ROSIGLITAZONE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 omeprazole, caffeine, flurbiprofen, rosiglitazone in United States
omeprazole, caffeine, flurbiprofen, rosiglitazone (omeprazole, caffeine, flurbiprofen, rosiglitazone) regulatory status in United States.
Marketing authorisations
FDA
- Application: ANDA078023
- Marketing authorisation holder: WATSON LABS
- Local brand name: ROSIGLITAZONE
- Indication: TABLET — ORAL
- Status: approved
omeprazole, caffeine, flurbiprofen, rosiglitazone 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 omeprazole, caffeine, flurbiprofen, rosiglitazone approved in United States?
Yes. FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for omeprazole, caffeine, flurbiprofen, rosiglitazone in United States?
DR REDDYS LABS INC holds the US marketing authorisation.