FDA — authorised 27 August 2020
- Application: NDA209575
- Marketing authorisation holder: OMNIVIUM PHARMS
- Indication: Labeling
- Status: approved
🇺🇸 COCAINE HYDROCHLORIDE in United States
FDA authorised COCAINE HYDROCHLORIDE on 27 August 2020 · 272 US adverse-event reports
Marketing authorisations
FDA — authorised 28 November 2022
- Application: NDA209963
- Marketing authorisation holder: LXO IRELAND
- Indication: Labeling
- 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: 272
Most-reported reactions
- Toxicity To Various Agents — 44 reports (16.18%)
- Drug Abuse — 40 reports (14.71%)
- Cardiac Arrest — 30 reports (11.03%)
- Death — 28 reports (10.29%)
- Respiratory Arrest — 27 reports (9.93%)
- Product Use Issue — 26 reports (9.56%)
- Suicidal Ideation — 20 reports (7.35%)
- Suspected Suicide — 20 reports (7.35%)
- Intentional Product Misuse — 19 reports (6.99%)
- Drug Dependence — 18 reports (6.62%)
COCAINE HYDROCHLORIDE 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 COCAINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 27 August 2020; FDA authorised it on 28 November 2022.
Who is the marketing authorisation holder for COCAINE HYDROCHLORIDE in United States?
OMNIVIUM PHARMS holds the US marketing authorisation.