FDA — authorised 14 May 1998
- Application: NDA019781
- Marketing authorisation holder: ACERTIS PHARMS
- Local brand name: PROMETRIUM
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Progesterone 200 MG in United States
FDA authorised Progesterone 200 MG on 14 May 1998
Marketing authorisations
FDA — authorised 16 December 1998
- Application: NDA020843
- Marketing authorisation holder: VIRTUS PHARMS
- Local brand name: PROMETRIUM
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Status: approved
Progesterone 200 MG 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 200 MG approved in United States?
Yes. FDA authorised it on 14 May 1998; FDA authorised it on 16 December 1998; FDA has authorised it.
Who is the marketing authorisation holder for Progesterone 200 MG in United States?
ACERTIS PHARMS holds the US marketing authorisation.