FDA — authorised 26 March 1957
- Application: NDA050168
- Marketing authorisation holder: MONARCH PHARMS
- Local brand name: CORTISPORIN
- Indication: OINTMENT — TOPICAL
- Status: approved
🇺🇸 Cortisporin in United States
FDA authorised Cortisporin on 26 March 1957
Marketing authorisations
FDA — authorised 26 March 1957
- Marketing authorisation holder: MONARCH PHARMS
- Status: approved
FDA — authorised 16 April 1963
- Application: NDA050218
- Marketing authorisation holder: MONARCH PHARMS
- Local brand name: CORTISPORIN
- Indication: CREAM — TOPICAL
- Status: approved
FDA — authorised 16 April 1964
- Application: NDA050356
- Marketing authorisation holder: PH HEALTH
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 18 December 1964
- Application: NDA050169
- Marketing authorisation holder: MONARCH PHARMS
- Local brand name: CORTISPORIN
- Indication: SUSPENSION/DROPS — OPHTHALMIC
- Status: approved
FDA — authorised 3 December 1993
- Application: ANDA062423
- Marketing authorisation holder: SANDOZ
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 23 July 1997
- Application: ANDA064063
- Marketing authorisation holder: BAUSCH AND LOMB
- Indication: Labeling
- Status: approved
FDA — authorised 7 June 1999
- Application: ANDA064053
- Marketing authorisation holder: BAUSCH AND LOMB
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 7 March 2001
- Application: ANDA064047
- Marketing authorisation holder: BAUSCH AND LOMB
- Indication: Manufacturing (CMC)
- Status: approved
Cortisporin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Cortisporin approved in United States?
Yes. FDA authorised it on 26 March 1957; FDA authorised it on 26 March 1957; FDA authorised it on 16 April 1963.
Who is the marketing authorisation holder for Cortisporin in United States?
MONARCH PHARMS holds the US marketing authorisation.