FDA — authorised 13 August 1947
- Marketing authorisation holder: ROXANE
- Status: approved
🇺🇸 Methadone Hydrochloride in United States
FDA authorised Methadone Hydrochloride on 13 August 1947
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 14 March 1973
- Application: NDA017058
- Marketing authorisation holder: HIKMA
- Local brand name: METHADONE HYDROCHLORIDE
- Indication: TABLET, FOR SUSPENSION — 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 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 17 August 2015
- Application: ANDA075082
- Marketing authorisation holder: VISTAPHARM LLC
- Indication: Labeling
- 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
The FDA approved Methadone Hydrochloride for use in the United States. This approval was granted to ELITE LABS INC on 22 December 2025, under application number ANDA210484. The approved indication for Methadone Hydrochloride is for use as described in the labelling.
FDA — authorised 2 October 2019
- Application: ANDA207537
- Marketing authorisation holder: SPECGX LLC
- Local brand name: METHADONE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 7 October 2019
- Application: NDA021624
- Marketing authorisation holder: MYLAN INSTITUTIONAL
- Indication: Labeling
- 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 13 September 2021
- Application: NDA017116
- Marketing authorisation holder: SPECGX LLC
- Indication: Labeling
- Status: approved
FDA — authorised 27 September 2023
- Application: ANDA204166
- Marketing authorisation holder: VISTAPHARM LLC
- Indication: Labeling
- Status: approved
FDA — authorised 16 December 2024
- Application: ANDA218252
- Marketing authorisation holder: BRECKENRIDGE
- Local brand name: METHADONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
Methadone Hydrochloride in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
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 14 March 1973.
Who is the marketing authorisation holder for Methadone Hydrochloride in United States?
ROXANE holds the US marketing authorisation.