FDA — authorised 14 June 1996
- Application: NDA020571
- Marketing authorisation holder: PFIZER INC
- Local brand name: CAMPTOSAR
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Camptosar in United States
FDA authorised Camptosar on 14 June 1996
Marketing authorisations
FDA — authorised 26 May 2017
- Application: ANDA206935
- Marketing authorisation holder: NOVAST LABS
- Status: approved
FDA — authorised 14 May 2020
- Application: ANDA212993
- Marketing authorisation holder: GLAND
- Indication: Labeling
- Status: approved
FDA — authorised 3 June 2020
- Application: ANDA203380
- Marketing authorisation holder: QILU PHARM HAINAN
- Indication: Labeling
- Status: approved
FDA — authorised 23 May 2025
- Application: ANDA090675
- Marketing authorisation holder: HENGRUI PHARMA
- Indication: Labeling
- Status: approved
The FDA approved Camptosar, a drug product, for marketing in the United States on 2025-05-23. The application number for this approval is ANDA090675. Camptosar was approved through the standard expedited pathway. The marketing authorisation holder for Camptosar is HENGRUI PHARMA.
FDA — authorised 20 August 2025
- Application: ANDA077776
- Marketing authorisation holder: FRESENIUS KABI USA
- Indication: Labeling
- Status: approved
The FDA approved Camptosar, manufactured by FRESENIUS KABI USA, on 2025-08-20. This approval was granted under the standard expedited pathway. Camptosar is indicated for use in the labelling provided by the agency.
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 14 June 1996; FDA authorised it on 26 May 2017; FDA authorised it on 14 May 2020.
Who is the marketing authorisation holder for Camptosar in United States?
PFIZER INC holds the US marketing authorisation.