FDA — authorised 19 July 1985
- Application: NDA050578
- Marketing authorisation holder: PAI HOLDINGS PHARM
- Local brand name: FORTAZ
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Fortaz in United States
FDA authorised Fortaz on 19 July 1985
Marketing authorisations
FDA — authorised 20 November 1985
- Application: ANDA062640
- Marketing authorisation holder: ACS DOBFAR
- Local brand name: CEFTAZIDIME
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 20 November 1985
- Application: ANDA062655
- Marketing authorisation holder: LILLY
- Local brand name: TAZIDIME
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 10 July 1986
- Application: ANDA062739
- Marketing authorisation holder: LILLY
- Local brand name: TAZIDIME IN PLASTIC CONTAINER
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 September 1990
- Application: NDA050646
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: CEPTAZ
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 November 1992
- Application: ANDA062662
- Marketing authorisation holder: HOSPIRA
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 28 November 2005
- Application: ANDA064032
- Marketing authorisation holder: HOSPIRA
- Indication: Labeling
- Status: approved
FDA — authorised 26 January 2017
- Application: NDA206494
- Marketing authorisation holder: ABBVIE
- Indication: Efficacy
- Status: approved
FDA
- Application: ANDA063322
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: PENTACEF
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA064006
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: PENTACEF
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA064008
- Marketing authorisation holder: GLAXOSMITHKLINE
- Local brand name: PENTACEF
- Indication: INJECTABLE — INJECTION
- Status: approved
Fortaz in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in United States
Frequently asked questions
Is Fortaz approved in United States?
Yes. FDA authorised it on 19 July 1985; FDA authorised it on 20 November 1985; FDA authorised it on 20 November 1985.
Who is the marketing authorisation holder for Fortaz in United States?
PAI HOLDINGS PHARM holds the US marketing authorisation.