FDA — authorised 1 November 1974
- Application: NDA009238
- Marketing authorisation holder: LILLY
- Local brand name: PROGESTERONE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Progesterone oral capsule in United States
FDA authorised Progesterone oral capsule on 1 November 1974
Marketing authorisations
FDA — authorised 11 May 1978
- Application: NDA017362
- Marketing authorisation holder: ACTAVIS LABS UT INC
- Local brand name: PROGESTERONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 April 2001
- Application: ANDA075906
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: PROGESTERONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 June 2009
- Application: ANDA090845
- Marketing authorisation holder: AM REGENT
- Local brand name: PROGESTERONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 October 2010
- Application: ANDA091033
- Marketing authorisation holder: HIKMA FARMACEUTICA
- Local brand name: PROGESTERONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 February 2012
- Application: ANDA202121
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: PROGESTERONE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 September 2012
- Application: ANDA200456
- Marketing authorisation holder: SOFGEN PHARMS
- Local brand name: PROGESTERONE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 16 August 2013
- Application: ANDA200900
- Marketing authorisation holder: BIONPHARMA
- Local brand name: PROGESTERONE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 February 2017
- Application: ANDA208801
- Marketing authorisation holder: DR REDDYS
- Local brand name: PROGESTERONE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 7 September 2017
- Application: ANDA207724
- Marketing authorisation holder: AMNEAL PHARMS NY
- Local brand name: PROGESTERONE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 20 October 2017
- Application: ANDA205229
- Marketing authorisation holder: XIROMED
- Local brand name: PROGESTERONE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 April 2020
- Application: NDA201110
- Marketing authorisation holder: FERRING PHARMS INC
- Local brand name: MILPROSA
- Indication: SYSTEM — VAGINAL
- Status: approved
FDA — authorised 5 January 2022
- Application: ANDA215634
- Marketing authorisation holder: XIROMED
- Local brand name: PROGESTERONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 November 2023
- Application: ANDA217707
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: PROGESTERONE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 September 2025
- Application: ANDA218391
- Marketing authorisation holder: XIROMED
- Local brand name: PROGESTERONE
- Indication: INSERT — VAGINAL
- Status: approved
FDA
- Status: approved
Progesterone oral capsule 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 Progesterone oral capsule approved in United States?
Yes. FDA authorised it on 1 November 1974; FDA authorised it on 11 May 1978; FDA authorised it on 25 April 2001.
Who is the marketing authorisation holder for Progesterone oral capsule in United States?
LILLY holds the US marketing authorisation.