FDA — authorised 18 June 1959
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Status: approved
🇺🇸 Depo-Provera in United States
FDA authorised Depo-Provera on 18 June 1959
Marketing authorisations
FDA — authorised 28 April 1978
- Application: ANDA085686
- Marketing authorisation holder: SOLVAY
- Local brand name: CURRETAB
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 December 1999
- Application: ANDA040311
- Marketing authorisation holder: DURAMED PHARMS BARR
- Local brand name: MEDROXYPROGESTERONE ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 July 2004
- Application: ANDA076553
- Marketing authorisation holder: HONG KONG
- Local brand name: MEDROXYPROGESTERONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 October 2004
- Application: ANDA076552
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: MEDROXYPROGESTERONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 November 2017
- Application: ANDA077334
- Marketing authorisation holder: AMPHASTAR PHARMS INC
- Local brand name: MEDROXYPROGESTERONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 January 2019
- Application: ANDA210335
- Marketing authorisation holder: CIPLA
- Local brand name: MEDROXYPROGESTERONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 April 2019
- Application: ANDA210761
- Marketing authorisation holder: SUN PHARM
- Local brand name: MEDROXYPROGESTERONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 May 2019
- Application: ANDA210760
- Marketing authorisation holder: SUN PHARM
- Local brand name: MEDROXYPROGESTERONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 August 2022
- Application: ANDA212824
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: MEDROXYPROGESTERONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 August 2022
- Application: ANDA212844
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: MEDROXYPROGESTERONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 5 January 2023
- Application: ANDA214309
- Marketing authorisation holder: HIKMA
- Local brand name: MEDROXYPROGESTERONE ACETATE
- Indication: INJECTABLE — INJECTION
- Status: approved
Depo-Provera in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Depo-Provera approved in United States?
Yes. FDA authorised it on 18 June 1959; FDA authorised it on 28 April 1978; FDA authorised it on 1 December 1999.
Who is the marketing authorisation holder for Depo-Provera in United States?
PHARMACIA AND UPJOHN holds the US marketing authorisation.