FDA — authorised 11 August 1999
- Application: NDA021029
- Marketing authorisation holder: MERCK SHARP DOHME
- Local brand name: TEMODAR
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 Temodar in United States
FDA authorised Temodar on 11 August 1999
Marketing authorisations
FDA — authorised 27 February 2009
- Application: NDA022277
- Marketing authorisation holder: MERCK SHARP DOHME
- Local brand name: TEMODAR
- Indication: POWDER — INTRAVENOUS
- Status: approved
FDA — authorised 1 March 2010
- Application: ANDA078879
- Marketing authorisation holder: HERITAGE
- Local brand name: TEMOZOLOMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 12 February 2014
- Application: ANDA201742
- Marketing authorisation holder: SUN PHARM
- Local brand name: TEMOZOLOMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 8 May 2015
- Application: ANDA203691
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: TEMOZOLOMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 12 April 2016
- Application: ANDA206413
- Marketing authorisation holder: CHARTWELL
- Local brand name: TEMOZOLOMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 27 April 2016
- Application: ANDA206309
- Marketing authorisation holder: RISING
- Local brand name: TEMOZOLOMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 June 2016
- Application: ANDA205227
- Marketing authorisation holder: EXTROVIS
- Local brand name: TEMOZOLOMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 27 February 2017
- Application: ANDA201528
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: TEMOZOLOMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 18 April 2017
- Application: ANDA203959
- Marketing authorisation holder: WATSON LABS TEVA
- Local brand name: TEMOZOLOMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 26 April 2017
- Application: ANDA207658
- Marketing authorisation holder: DEVA HOLDING AS
- Local brand name: TEMOZOLOMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 31 July 2017
- Application: ANDA206750
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: TEMOZOLOMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 5 July 2018
- Application: ANDA204159
- Marketing authorisation holder: APOTEX
- Local brand name: TEMOZOLOMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 23 November 2021
- Application: ANDA213328
- Marketing authorisation holder: NIVAGEN PHARMS INC
- Local brand name: TEMOZOLOMIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 23 August 2024
- Application: ANDA210030
- Marketing authorisation holder: HETERO LABS LTD V
- Local brand name: TEMOZOLOMIDE
- Indication: CAPSULE — ORAL
- Status: approved
Temodar 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 Temodar approved in United States?
Yes. FDA authorised it on 11 August 1999; FDA authorised it on 27 February 2009; FDA authorised it on 1 March 2010.
Who is the marketing authorisation holder for Temodar in United States?
MERCK SHARP DOHME holds the US marketing authorisation.