FDA — authorised 13 February 2017
- Application: ANDA207952
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: LOGILIA
- Indication: TABLET — ORAL
- Status: approved
FDA authorised PGL4001, progestin, drug free period on 13 February 2017
Yes. FDA authorised it on 13 February 2017.
TEVA PHARMS USA holds the US marketing authorisation.