FDA — authorised 25 August 1982
- Application: ANDA062365
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: CHLORAMPHENICOL SODIUM SUCCINATE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 CHLORAMPHENICOL SODIUM SUCCINATE in United States
FDA authorised CHLORAMPHENICOL SODIUM SUCCINATE on 25 August 1982 · 26 US adverse-event reports
Marketing authorisations
FDA
- Application: ANDA060132
- Marketing authorisation holder: ANGUS
- Local brand name: MYCHEL-S
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA062278
- Marketing authorisation holder: GRUPPO LEPETIT
- Local brand name: CHLORAMPHENICOL SODIUM SUCCINATE
- Indication: INJECTABLE — INJECTION
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 26
Most-reported reactions
- Grey Syndrome Neonatal — 4 reports (15.38%)
- Headache — 3 reports (11.54%)
- Lethargy — 3 reports (11.54%)
- Metabolic Acidosis — 3 reports (11.54%)
- Pyrexia — 3 reports (11.54%)
- Alanine Aminotransferase Increased — 2 reports (7.69%)
- Apnoea — 2 reports (7.69%)
- Condition Aggravated — 2 reports (7.69%)
- Dehydration — 2 reports (7.69%)
- Drug Level Increased — 2 reports (7.69%)
CHLORAMPHENICOL SODIUM SUCCINATE 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 CHLORAMPHENICOL SODIUM SUCCINATE approved in United States?
Yes. FDA authorised it on 25 August 1982; FDA has authorised it; FDA has authorised it.
Who is the marketing authorisation holder for CHLORAMPHENICOL SODIUM SUCCINATE in United States?
FRESENIUS KABI USA holds the US marketing authorisation.