FDA — authorised 18 August 1971
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Status: approved
🇺🇸 Megace in United States
FDA authorised Megace on 18 August 1971
Marketing authorisations
FDA — authorised 18 August 1971
- Application: NDA016979
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: MEGACE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 September 1993
- Application: NDA020264
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: MEGACE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 30 November 1995
- Application: ANDA074621
- Marketing authorisation holder: BARR
- Local brand name: MEGESTROL ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 February 1998
- Application: ANDA074745
- Marketing authorisation holder: TEVA
- Local brand name: MEGESTROL ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 July 2001
- Application: ANDA075671
- Marketing authorisation holder: STRIDES PHARMA INTL
- Local brand name: MEGESTROL ACETATE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 5 May 2003
- Application: ANDA075681
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: MEGESTROL ACETATE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 16 February 2006
- Application: ANDA077404
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: MEGESTROL ACETATE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 9 June 2017
- Application: ANDA203960
- Marketing authorisation holder: HIKMA
- Local brand name: MEGESTROL ACETATE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA — authorised 1 December 2017
- Application: ANDA204688
- Marketing authorisation holder: CHARTWELL
- Local brand name: MEGESTROL ACETATE
- Indication: SUSPENSION — ORAL
- Status: approved
FDA
- Application: ANDA070647
- Marketing authorisation holder: USL PHARMA
- Local brand name: MEGESTROL ACETATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070646
- Marketing authorisation holder: USL PHARMA
- Local brand name: MEGESTROL ACETATE
- Indication: TABLET — ORAL
- Status: approved
Megace in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Megace approved in United States?
Yes. FDA authorised it on 18 August 1971; FDA authorised it on 18 August 1971; FDA authorised it on 10 September 1993.
Who is the marketing authorisation holder for Megace in United States?
BRISTOL MYERS SQUIBB holds the US marketing authorisation.