FDA — authorised 28 August 1986
- Application: ANDA070990
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: DACARBAZINE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 DACARBAZINE in United States
FDA authorised DACARBAZINE on 28 August 1986
Marketing authorisations
FDA — authorised 28 August 1986
- Application: ANDA070962
- Marketing authorisation holder: ABRAXIS PHARM
- Local brand name: DACARBAZINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 August 1998
- Application: ANDA075259
- Marketing authorisation holder: MEITHEAL
- Local brand name: DACARBAZINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 June 2001
- Application: ANDA075812
- Marketing authorisation holder: HIKMA
- Local brand name: DACARBAZINE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Status: approved
DACARBAZINE 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 DACARBAZINE approved in United States?
Yes. FDA authorised it on 28 August 1986; FDA authorised it on 28 August 1986; FDA authorised it on 27 August 1998.
Who is the marketing authorisation holder for DACARBAZINE in United States?
ABRAXIS PHARM holds the US marketing authorisation.