FDA — authorised 20 February 2008
- Application: ANDA077219
- Marketing authorisation holder: CIPLA LTD
- Local brand name: IRINOTECAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Camptosar in United States
FDA authorised Camptosar on 20 February 2008
Marketing authorisations
FDA — authorised 27 February 2008
- Application: ANDA077915
- Marketing authorisation holder: HOSPIRA
- Local brand name: IRINOTECAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 February 2008
- Application: ANDA078589
- Marketing authorisation holder: ACTAVIS TOTOWA
- Local brand name: IRINOTECAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 February 2008
- Application: ANDA077260
- Marketing authorisation holder: TEVA PARENTERAL
- Local brand name: IRINOTECAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 February 2008
- Application: ANDA077776
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: IRINOTECAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FRESENIUS KABI USA was granted marketing authorisation by the FDA for Camptosar on 2025-08-20. Camptosar is a drug used in the treatment of various cancers. The marketing authorisation was approved through a standard expedited pathway.
FDA — authorised 27 February 2008
- Application: ANDA077994
- Marketing authorisation holder: SANDOZ
- Local brand name: IRINOTECAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 April 2008
- Application: ANDA078805
- Marketing authorisation holder: SUN PHARMA GLOBAL
- Local brand name: IRINOTECAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 October 2008
- Application: ANDA078122
- Marketing authorisation holder: PLIVA LACHEMA
- Local brand name: IRINOTECAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 November 2008
- Application: ANDA079068
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: IRINOTECAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 November 2008
- Application: ANDA090101
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: IRINOTECAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 24 December 2008
- Application: ANDA078753
- Marketing authorisation holder: HIKMA
- Local brand name: IRINOTECAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 January 2009
- Application: ANDA090016
- Marketing authorisation holder: HISUN PHARM HANGZHOU
- Local brand name: IRINOTECAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 November 2009
- Application: ANDA090137
- Marketing authorisation holder: SANDOZ
- Local brand name: IRINOTECAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 April 2010
- Application: ANDA078953
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: IRINOTECAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 December 2010
- Application: ANDA091032
- Marketing authorisation holder: HIKMA FARMACEUTICA
- Local brand name: IRINOTECAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 December 2011
- Application: ANDA090675
- Marketing authorisation holder: HENGRUI PHARMA
- Local brand name: IRINOTECAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
The FDA approved Camptosar, a drug product, for its labelled indication. The approval was granted to HENGRUI PHARMA on 2025-05-23. Camptosar was approved through the standard expedited pathway.
FDA — authorised 14 February 2012
- Application: ANDA200771
- Marketing authorisation holder: EMCURE PHARMS LTD
- Local brand name: IRINOTECAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 May 2016
- Application: ANDA203380
- Marketing authorisation holder: QILU PHARM HAINAN
- Local brand name: IRINOTECAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 26 May 2017
- Application: ANDA206935
- Marketing authorisation holder: NOVAST LABS
- Local brand name: IRINOTECAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 August 2017
- Application: ANDA203054
- Marketing authorisation holder: INTAS PHARMS USA
- Local brand name: IRINOTECAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 December 2018
- Application: ANDA208718
- Marketing authorisation holder: SHILPA
- Local brand name: IRINOTECAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 November 2019
- Application: ANDA212993
- Marketing authorisation holder: GLAND
- Local brand name: IRINOTECAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 2 November 2020
- Application: ANDA213278
- Marketing authorisation holder: EUGIA PHARMA
- Local brand name: IRINOTECAN HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
Camptosar 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 Camptosar approved in United States?
Yes. FDA authorised it on 20 February 2008; FDA authorised it on 27 February 2008; FDA authorised it on 27 February 2008.
Who is the marketing authorisation holder for Camptosar in United States?
CIPLA LTD holds the US marketing authorisation.