FDA — authorised 8 January 2014
- Application: ANDA201676
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: SIROLIMUS
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Rapamune Pill in United States
FDA authorised Rapamune Pill on 8 January 2014
Marketing authorisations
FDA — authorised 27 October 2014
- Application: ANDA201578
- Marketing authorisation holder: DR REDDYS
- Local brand name: SIROLIMUS
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 October 2019
- Application: ANDA211406
- Marketing authorisation holder: APOTEX
- Local brand name: SIROLIMUS
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 16 October 2020
- Application: ANDA208691
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: SIROLIMUS
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 July 2025
- Application: ANDA215116
- Marketing authorisation holder: RISING
- Local brand name: SIROLIMUS
- Indication: SOLUTION — ORAL
- Status: approved
Frequently asked questions
Is Rapamune Pill approved in United States?
Yes. FDA authorised it on 8 January 2014; FDA authorised it on 27 October 2014; FDA authorised it on 22 October 2019.
Who is the marketing authorisation holder for Rapamune Pill in United States?
ZYDUS PHARMS holds the US marketing authorisation.