🇺🇸 Dacarbazine (DTIC) in United States

FDA authorised Dacarbazine (DTIC) on 27 May 1975 · 3 US adverse-event reports

Marketing authorisation

FDA — authorised 27 May 1975

  • Application: NDA017575
  • Marketing authorisation holder: BAYER HLTHCARE
  • Local brand name: DTIC-DOME
  • Indication: INJECTABLE — INJECTION
  • Status: approved

Read official source →

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Failed Trial Of Labour — 1 report (33.33%)
  2. Maternal Exposure During Pregnancy — 1 report (33.33%)
  3. Postpartum Haemorrhage — 1 report (33.33%)

Source database →

Other Oncology approved in United States

Frequently asked questions

Is Dacarbazine (DTIC) approved in United States?

Yes. FDA authorised it on 27 May 1975.

Who is the marketing authorisation holder for Dacarbazine (DTIC) in United States?

BAYER HLTHCARE holds the US marketing authorisation.