FDA — authorised 21 June 1955
- Application: NDA009986
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Local brand name: DELTASONE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Prednisone 5 mg in United States
FDA authorised Prednisone 5 mg on 21 June 1955
Marketing authorisations
FDA — authorised 29 January 1974
- Application: ANDA083009
- Marketing authorisation holder: SOLVAY
- Local brand name: ORASONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 December 1975
- Application: ANDA084655
- Marketing authorisation holder: SCHWARZ PHARMA
- Local brand name: PREDNICEN-M
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA085999
- Marketing authorisation holder: SOLVAY
- Local brand name: ORASONE
- Indication: TABLET — ORAL
- Status: approved
Prednisone 5 mg 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 Prednisone 5 mg approved in United States?
Yes. FDA authorised it on 21 June 1955; FDA authorised it on 29 January 1974; FDA authorised it on 9 December 1975.
Who is the marketing authorisation holder for Prednisone 5 mg in United States?
PHARMACIA AND UPJOHN holds the US marketing authorisation.