FDA — authorised 31 December 1986
- Application: NDA050580
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: AZACTAM
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 AZACTAM in United States
FDA authorised AZACTAM on 31 December 1986
Marketing authorisations
FDA
- Status: approved
AZACTAM 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 AZACTAM approved in United States?
Yes. FDA authorised it on 31 December 1986; FDA has authorised it.
Who is the marketing authorisation holder for AZACTAM in United States?
BRISTOL MYERS SQUIBB holds the US marketing authorisation.