FDA — authorised 8 December 1950
- Marketing authorisation holder: PARKEDALE
- Status: approved
🇺🇸 Chloromycetin in United States
FDA authorised Chloromycetin on 8 December 1950
Marketing authorisations
FDA — authorised 1 June 1951
- Application: NDA050143
- Marketing authorisation holder: PARKEDALE
- Local brand name: CHLOROMYCETIN
- Indication: FOR SOLUTION — OPHTHALMIC
- Status: approved
FDA — authorised 1 June 1951
- Application: NDA050156
- Marketing authorisation holder: PARKEDALE
- Local brand name: CHLOROMYCETIN
- Indication: OINTMENT — OPHTHALMIC
- Status: approved
FDA — authorised 30 March 1953
- Application: NDA050205
- Marketing authorisation holder: PARKEDALE
- Local brand name: CHLOROMYCETIN
- Indication: SOLUTION/DROPS — OTIC
- Status: approved
FDA — authorised 20 February 1959
- Application: NDA050155
- Marketing authorisation holder: PARKEDALE
- Local brand name: CHLOROMYCETIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: NDA050153
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: CHLOROMYCETIN
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: NDA050183
- Marketing authorisation holder: PARKE DAVIS
- Local brand name: CHLOROMYCETIN
- Indication: CREAM — TOPICAL
- Status: approved
Chloromycetin in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Infectious Disease approved in United States
Frequently asked questions
Is Chloromycetin approved in United States?
Yes. FDA authorised it on 8 December 1950; FDA authorised it on 1 June 1951; FDA authorised it on 1 June 1951.
Who is the marketing authorisation holder for Chloromycetin in United States?
PARKEDALE holds the US marketing authorisation.