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 — authorised 24 May 1989
- Application: NDA050632
- Marketing authorisation holder: BRISTOL MYERS SQUIBB
- Local brand name: AZACTAM IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 June 2010
- Application: ANDA065439
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: AZTREONAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 March 2011
- Application: ANDA065286
- Marketing authorisation holder: HIKMA
- Local brand name: AZTREONAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 8 November 2021
- Application: ANDA206517
- Marketing authorisation holder: HOSPIRA
- Local brand name: AZTREONAM
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 5 February 2026
- Application: ANDA207069
- Marketing authorisation holder: HIKMA
- Local brand name: AZTREONAM
- Indication: INJECTABLE — INJECTION
- Status: approved
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.
Other Infectious Disease approved in United States
Frequently asked questions
Is Azactam approved in United States?
Yes. FDA authorised it on 31 December 1986; FDA authorised it on 24 May 1989; FDA authorised it on 18 June 2010.
Who is the marketing authorisation holder for Azactam in United States?
BRISTOL MYERS SQUIBB holds the US marketing authorisation.