FDA — authorised 13 February 1974
- Application: ANDA080258
- Marketing authorisation holder: PARKE-DAVIS
- Status: supplemented
🇺🇸 Group C ("Standard-of-Care") in United States
FDA authorised Group C ("Standard-of-Care") on 13 February 1974
Marketing authorisations
FDA — authorised 17 October 1974
- Application: ANDA080767
- Marketing authorisation holder: IMPAX LABS
- Status: supplemented
FDA — authorised 27 August 1976
- Application: ANDA084349
- Marketing authorisation holder: VIATRIS
- Status: supplemented
FDA — authorised 1 October 2004
- Application: NDA021735
- Marketing authorisation holder: FOUGERA PHARMS INC
- Status: supplemented
FDA — authorised 17 March 2017
- Application: ANDA206941
- Marketing authorisation holder: AUROBINDO PHARMA
- Status: approved
Frequently asked questions
Is Group C ("Standard-of-Care") approved in United States?
Yes. FDA authorised it on 13 February 1974; FDA authorised it on 17 October 1974; FDA authorised it on 27 August 1976.
Who is the marketing authorisation holder for Group C ("Standard-of-Care") in United States?
PARKE-DAVIS holds the US marketing authorisation.