FDA — authorised 13 August 1947
- Application: NDA021624
- Marketing authorisation holder: MYLAN INSTITUTIONAL
- Local brand name: METHADONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 METHADONE HYDROCHLORIDE in United States
FDA authorised METHADONE HYDROCHLORIDE on 13 August 1947 · 5,203 US adverse-event reports
Marketing authorisations
FDA — authorised 13 August 1947
- Application: NDA006134
- Marketing authorisation holder: HIKMA
- Local brand name: DOLOPHINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 December 1947
- Application: NDA006383
- Marketing authorisation holder: MALLINCKRODT INC
- Local brand name: METHADONE HYDROCHLORIDE
- Indication: POWDER — FOR RX COMPOUNDING
- Status: approved
FDA — authorised 14 March 1973
- Application: NDA017108
- Marketing authorisation holder: SANDOZ
- Local brand name: WESTADONE
- Indication: TABLET, EFFERVESCENT — ORAL
- Status: approved
FDA — authorised 14 March 1973
- Application: NDA017058
- Marketing authorisation holder: HIKMA
- Local brand name: METHADONE HYDROCHLORIDE
- Indication: TABLET, FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 22 May 1981
- Application: ANDA087393
- Marketing authorisation holder: HIKMA
- Local brand name: METHADONE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 30 August 1982
- Application: ANDA087997
- Marketing authorisation holder: HIKMA
- Local brand name: METHADONE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 8 March 1983
- Application: ANDA088109
- Marketing authorisation holder: HIKMA
- Local brand name: METHADONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 6 September 1988
- Application: ANDA089897
- Marketing authorisation holder: HIKMA
- Local brand name: METHADONE HYDROCHLORIDE INTENSOL
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA — authorised 30 November 1994
- Application: ANDA040088
- Marketing authorisation holder: VISTAPHARM LLC
- Local brand name: METHADONE HYDROCHLORIDE
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA — authorised 28 April 1995
- Application: ANDA074081
- Marketing authorisation holder: ROXANE
- Local brand name: METHADONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 March 1998
- Application: ANDA075082
- Marketing authorisation holder: VISTAPHARM LLC
- Local brand name: METHADONE HYDROCHLORIDE
- Indication: TABLET, FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 29 May 1998
- Application: ANDA040241
- Marketing authorisation holder: VISTAPHARM LLC
- Local brand name: METHADONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 April 2004
- Application: ANDA040517
- Marketing authorisation holder: SPECGX LLC
- Local brand name: METHADONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 July 2005
- Application: ANDA077142
- Marketing authorisation holder: SPECGX LLC
- Local brand name: METHADONE HYDROCHLORIDE
- Indication: TABLET, FOR SUSPENSION — ORAL
- Status: approved
FDA — authorised 25 November 2009
- Application: ANDA090635
- Marketing authorisation holder: THEPHARMANETWORK LLC
- Local brand name: METHADONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 October 2017
- Application: ANDA208306
- Marketing authorisation holder: LONG GROVE PHARMS
- Local brand name: METHADONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 March 2018
- Application: ANDA208305
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: METHADONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 August 2018
- Application: ANDA210484
- Marketing authorisation holder: ELITE LABS INC
- Local brand name: METHADONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 January 2019
- Application: ANDA211228
- Marketing authorisation holder: ASCENT PHARMS INC
- Local brand name: METHADONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 October 2019
- Application: ANDA207537
- Marketing authorisation holder: SPECGX LLC
- Local brand name: METHADONE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 16 March 2020
- Application: ANDA204166
- Marketing authorisation holder: VISTAPHARM LLC
- Local brand name: METHADONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 November 2020
- Application: ANDA212093
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: METHADONE HYDROCHLORIDE
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA — authorised 3 March 2021
- Application: ANDA212094
- Marketing authorisation holder: LANNETT CO INC
- Local brand name: METHADONE HYDROCHLORIDE
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA — authorised 16 December 2024
- Application: ANDA218252
- Marketing authorisation holder: BRECKENRIDGE
- Local brand name: METHADONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- 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: 5,203
Most-reported reactions
- Toxicity To Various Agents — 983 reports (18.89%)
- Overdose — 704 reports (13.53%)
- Drug Abuse — 606 reports (11.65%)
- Dependence — 528 reports (10.15%)
- Drug Dependence — 521 reports (10.01%)
- Death — 413 reports (7.94%)
- Foetal Exposure During Pregnancy — 412 reports (7.92%)
- Exposure During Pregnancy — 355 reports (6.82%)
- Pain — 345 reports (6.63%)
- Drug Withdrawal Syndrome Neonatal — 336 reports (6.46%)
METHADONE 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 METHADONE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 13 August 1947; FDA authorised it on 13 August 1947; FDA authorised it on 15 December 1947.
Who is the marketing authorisation holder for METHADONE HYDROCHLORIDE in United States?
MYLAN INSTITUTIONAL holds the US marketing authorisation.