FDA — authorised 16 July 2009
- Application: NDA022402
- Marketing authorisation holder: HIKMA
- Indication: Type 7 - Drug Already Marketed without Approved NDA
- Status: approved
🇺🇸 CODEINE SULFATE in United States
FDA authorised CODEINE SULFATE on 16 July 2009 · 4,178 US adverse-event reports
Marketing authorisations
FDA — authorised 30 June 2011
- Application: NDA202245
- Marketing authorisation holder: HIKMA
- Local brand name: CODEINE SULFATE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 13 June 2014
- Application: ANDA203046
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: CODEINE SULFATE
- Indication: TABLET — ORAL
- Status: approved
Lannett Co Inc has been granted marketing authorisation by the FDA for Codeine Sulfate. The approval was issued on 31 October 2024, under the Risk Evaluation and Mitigation Strategy (REMS) programme. This approval was granted via the standard expedited pathway, with application number ANDA203046.
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: 4,178
Most-reported reactions
- Drug Hypersensitivity — 823 reports (19.7%)
- Nausea — 504 reports (12.06%)
- Malaise — 382 reports (9.14%)
- Vomiting — 376 reports (9%)
- Drug Ineffective — 371 reports (8.88%)
- Headache — 365 reports (8.74%)
- Arthralgia — 360 reports (8.62%)
- Diarrhoea — 351 reports (8.4%)
- Dyspnoea — 338 reports (8.09%)
- Cough — 308 reports (7.37%)
CODEINE SULFATE 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 CODEINE SULFATE approved in United States?
Yes. FDA authorised it on 16 July 2009; FDA authorised it on 30 June 2011; FDA authorised it on 13 June 2014.
Who is the marketing authorisation holder for CODEINE SULFATE in United States?
HIKMA holds the US marketing authorisation.