FDA — authorised 25 February 2004
- Application: ANDA040529
- Marketing authorisation holder: ABLE
- Local brand name: METHAMPHETAMINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 METHAMPHETAMINE HYDROCHLORIDE in United States
FDA authorised METHAMPHETAMINE HYDROCHLORIDE on 25 February 2004 · 1,023 US adverse-event reports
Marketing authorisations
FDA — authorised 21 April 2010
- Application: ANDA091189
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: METHAMPHETAMINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 November 2015
- Application: ANDA203846
- Marketing authorisation holder: HIKMA
- Local brand name: METHAMPHETAMINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA086359
- Marketing authorisation holder: TEVA
- Local brand name: METHAMPHETAMINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- 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: 1,023
Most-reported reactions
- Toxicity To Various Agents — 265 reports (25.9%)
- Drug Abuse — 229 reports (22.39%)
- Completed Suicide — 90 reports (8.8%)
- Death — 90 reports (8.8%)
- Cardiac Arrest — 70 reports (6.84%)
- Drug Interaction — 68 reports (6.65%)
- Respiratory Arrest — 64 reports (6.26%)
- Cardio-Respiratory Arrest — 49 reports (4.79%)
- Overdose — 49 reports (4.79%)
- Substance Abuse — 49 reports (4.79%)
METHAMPHETAMINE 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 METHAMPHETAMINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 25 February 2004; FDA authorised it on 21 April 2010; FDA authorised it on 17 November 2015.
Who is the marketing authorisation holder for METHAMPHETAMINE HYDROCHLORIDE in United States?
ABLE holds the US marketing authorisation.