FDA — authorised 13 May 1997
- Application: NDA020756
- Marketing authorisation holder: WATSON LABS INC
- Local brand name: CRINONE
- Indication: GEL — VAGINAL
- Status: approved
🇺🇸 Progesterone Vaginal Gel with Applicator in United States
FDA authorised Progesterone Vaginal Gel with Applicator on 13 May 1997
Marketing authorisations
FDA — authorised 31 July 1997
- Application: NDA020701
- Marketing authorisation holder: ABBVIE
- Local brand name: CRINONE
- Indication: GEL — VAGINAL
- Status: approved
Other Women's Health approved in United States
Frequently asked questions
Is Progesterone Vaginal Gel with Applicator approved in United States?
Yes. FDA authorised it on 13 May 1997; FDA authorised it on 31 July 1997.
Who is the marketing authorisation holder for Progesterone Vaginal Gel with Applicator in United States?
WATSON LABS INC holds the US marketing authorisation.