FDA — authorised 26 May 1995
- Marketing authorisation holder: PHARMACIA AND UPJOHN
- Status: approved
🇺🇸 Zinecard in United States
FDA authorised Zinecard on 26 May 1995
Marketing authorisations
FDA — authorised 26 May 1995
- Application: NDA020212
- Marketing authorisation holder: PFIZER
- Local brand name: ZINECARD
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 28 September 2004
- Application: ANDA076068
- Marketing authorisation holder: HIKMA
- Status: approved
FDA — authorised 19 October 2011
- Application: ANDA200752
- Marketing authorisation holder: EUGIA PHARMA
- Indication: Not Applicable
- Status: approved
FDA — authorised 28 November 2016
- Application: ANDA207321
- Marketing authorisation holder: GLAND
- Status: approved
FDA — authorised 26 March 2025
- Application: ANDA216748
- Marketing authorisation holder: MSN
- Status: approved
Zinecard in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in United States
Frequently asked questions
Is Zinecard approved in United States?
Yes. FDA authorised it on 26 May 1995; FDA authorised it on 26 May 1995; FDA authorised it on 28 September 2004.
Who is the marketing authorisation holder for Zinecard in United States?
PHARMACIA AND UPJOHN holds the US marketing authorisation.