FDA — authorised 10 March 2000
- Application: ANDA065031
- Marketing authorisation holder: HOSPIRA
- Local brand name: BLEOMYCIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 BLEOMYCIN SULFATE in United States
FDA authorised BLEOMYCIN SULFATE on 10 March 2000
Marketing authorisations
FDA — authorised 27 June 2000
- Application: ANDA065033
- Marketing authorisation holder: TEVA PHARMS USA
- Local brand name: BLEOMYCIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 October 2001
- Application: ANDA065042
- Marketing authorisation holder: HIKMA
- Local brand name: BLEOMYCIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 November 2011
- Application: ANDA065185
- Marketing authorisation holder: FRESENIUS KABI USA
- Indication: Labeling
- Status: approved
FDA — authorised 20 April 2018
- Application: ANDA205030
- Marketing authorisation holder: MEITHEAL
- Status: approved
FDA — authorised 11 March 2019
- Application: ANDA209439
- Marketing authorisation holder: CIPLA
- Local brand name: BLEOMYCIN SULFATE
- Indication: INJECTABLE — INJECTION
- Status: approved
BLEOMYCIN SULFATE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is BLEOMYCIN SULFATE approved in United States?
Yes. FDA authorised it on 10 March 2000; FDA authorised it on 27 June 2000; FDA authorised it on 17 October 2001.
Who is the marketing authorisation holder for BLEOMYCIN SULFATE in United States?
HOSPIRA holds the US marketing authorisation.