FDA — authorised 19 October 1983
- Application: NDA050558
- Marketing authorisation holder: PAI HOLDINGS PHARM
- Local brand name: ZINACEF
- Indication: INJECTABLE — INTRAMUSCULAR, INTRAVENOUS
- Status: approved
🇺🇸 Zinacef in United States
FDA authorised Zinacef on 19 October 1983
Marketing authorisations
FDA — authorised 19 October 1983
- Marketing authorisation holder: COVIS INJECTABLES
- Status: approved
FDA — authorised 9 January 2004
- Application: ANDA065048
- Marketing authorisation holder: HIKMA
- Local brand name: CEFUROXIME
- Indication: Injectable — Injection
- Status: approved
FDA — authorised 29 June 2004
- Application: NDA050780
- Marketing authorisation holder: B BRAUN
- Indication: Labeling
- Status: approved
FDA — authorised 21 December 2007
- Application: ANDA065308
- Marketing authorisation holder: AUROBINDO PHARMA
- Indication: Labeling
- Status: approved
FDA — authorised 25 August 2008
- Application: ANDA065046
- Marketing authorisation holder: HIKMA
- Indication: Labeling
- Status: approved
FDA — authorised 21 November 2012
- Application: ANDA064125
- Marketing authorisation holder: ACS DOBFAR SPA
- Indication: Labeling
- Status: approved
FDA — authorised 10 March 2017
- Application: ANDA065496
- Marketing authorisation holder: ALKEM LABS LTD
- Indication: Labeling
- Status: approved
Zinacef in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Cardiovascular approved in United States
Frequently asked questions
Is Zinacef approved in United States?
Yes. FDA authorised it on 19 October 1983; FDA authorised it on 19 October 1983; FDA authorised it on 9 January 2004.
Who is the marketing authorisation holder for Zinacef in United States?
PAI HOLDINGS PHARM holds the US marketing authorisation.