FDA — authorised 10 July 2002
- Application: ANDA076095
- Marketing authorisation holder: ANI PHARMS
- Local brand name: MISOPROSTOL
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Medical Management in United States
FDA authorised Medical Management on 10 July 2002
Marketing authorisations
FDA — authorised 25 July 2012
- Application: ANDA091667
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: MISOPROSTOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 11 April 2019
- Application: ANDA091178
- Marketing authorisation holder: GENBIOPRO
- Local brand name: MIFEPRISTONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 July 2019
- Application: ANDA210201
- Marketing authorisation holder: ACQ PHARMA
- Local brand name: MISOPROSTOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 August 2020
- Application: ANDA211436
- Marketing authorisation holder: TEVA PHARMS USA INC
- Local brand name: MIFEPRISTONE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 October 2022
- Application: ANDA216872
- Marketing authorisation holder: MICRO LABS
- Local brand name: MISOPROSTOL
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 September 2025
- Application: ANDA216616
- Marketing authorisation holder: EVITA SOLUTIONS
- Local brand name: MIFEPRISTONE
- Indication: TABLET — ORAL
- Status: approved
Frequently asked questions
Is Medical Management approved in United States?
Yes. FDA authorised it on 10 July 2002; FDA authorised it on 25 July 2012; FDA authorised it on 11 April 2019.
Who is the marketing authorisation holder for Medical Management in United States?
ANI PHARMS holds the US marketing authorisation.