FDA — authorised 24 November 2008
- Application: ANDA090193
- Marketing authorisation holder: AM REGENT
- Local brand name: METHYLERGONOVINE MALEATE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 METHYLERGONOVINE MALEATE in United States
FDA authorised METHYLERGONOVINE MALEATE on 24 November 2008
Marketing authorisations
FDA — authorised 13 September 2010
- Application: ANDA040889
- Marketing authorisation holder: BRECKENRIDGE
- Local brand name: METHYLERGONOVINE MALEATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 May 2011
- Application: ANDA091577
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: METHYLERGONOVINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 May 2018
- Application: ANDA210424
- Marketing authorisation holder: GRANULES
- Local brand name: METHYLERGONOVINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 September 2018
- Application: ANDA211483
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: METHYLERGONOVINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 20 March 2019
- Application: ANDA211455
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: METHYLERGONOVINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 May 2020
- Application: ANDA212233
- Marketing authorisation holder: TP ANDA HOLDINGS
- Local brand name: METHYLERGONOVINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 January 2021
- Application: ANDA211919
- Marketing authorisation holder: RISING
- Local brand name: METHYLERGONOVINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
METHYLERGONOVINE MALEATE 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 METHYLERGONOVINE MALEATE approved in United States?
Yes. FDA authorised it on 24 November 2008; FDA authorised it on 13 September 2010; FDA authorised it on 2 May 2011.
Who is the marketing authorisation holder for METHYLERGONOVINE MALEATE in United States?
AM REGENT holds the US marketing authorisation.