FDA — authorised 17 April 1961
- Application: NDA012657
- Marketing authorisation holder: SCHERING
- Local brand name: CELESTONE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Xylocaine and Celestone in United States
FDA authorised Xylocaine and Celestone on 17 April 1961
Marketing authorisations
FDA — authorised 13 April 1964
- Application: NDA014215
- Marketing authorisation holder: MERCK SHARP DOHME
- Local brand name: CELESTONE
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 31 December 1974
- Application: NDA017561
- Marketing authorisation holder: SCHERING
- Local brand name: CELESTONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
FDA
- Application: NDA014762
- Marketing authorisation holder: SCHERING
- Local brand name: CELESTONE
- Indication: CREAM — TOPICAL
- Status: approved
Xylocaine and Celestone 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 Xylocaine and Celestone approved in United States?
Yes. FDA authorised it on 17 April 1961; FDA authorised it on 13 April 1964; FDA authorised it on 31 December 1974.
Who is the marketing authorisation holder for Xylocaine and Celestone in United States?
SCHERING holds the US marketing authorisation.