FDA — authorised 28 June 2006
- Application: NDA022072
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: SPRYCEL
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 Sprycel in United States
FDA authorised Sprycel on 28 June 2006
Marketing authorisations
FDA — authorised 8 November 2007
- Application: NDA021986
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Indication: Efficacy
- Status: approved
FDA — authorised 10 June 2016
- Application: ANDA202103
- Marketing authorisation holder: APOTEX
- Local brand name: DASATINIB
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 23 November 2021
- Application: ANDA203180
- Marketing authorisation holder: APOTEX
- Local brand name: DASATINIB
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 5 December 2023
- Application: NDA216099
- Marketing authorisation holder: HANDA THERAP
- Local brand name: PHYRAGO
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 March 2025
- Application: ANDA218719
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: DASATINIB
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 3 March 2025
- Application: ANDA217217
- Marketing authorisation holder: BIOCON PHARMA
- Status: approved
FDA — authorised 22 April 2025
- Application: ANDA216547
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: DASATINIB
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 August 2025
- Application: ANDA214350
- Marketing authorisation holder: LUPIN
- Local brand name: DASATINIB
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 August 2025
- Application: ANDA211094
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: DASATINIB
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 September 2025
- Application: ANDA213383
- Marketing authorisation holder: DR REDDYS
- Indication: Labeling
- Status: approved
The FDA approved Sprycel for its indicated use. The approval was granted to DR REDDYS on 2025-09-30. The application number for this approval is ANDA213383.
FDA — authorised 6 November 2025
- Application: ANDA216261
- Marketing authorisation holder: ALEMBIC
- Status: approved
Sprycel 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 Sprycel approved in United States?
Yes. FDA authorised it on 28 June 2006; FDA authorised it on 8 November 2007; FDA authorised it on 10 June 2016.
Who is the marketing authorisation holder for Sprycel in United States?
BRISTOL MYERS SQUIBB holds the US marketing authorisation.