FDA — authorised 2 December 2015
- Application: ANDA078759
- Marketing authorisation holder: TEYRO LABS
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Gemzar in United States
FDA authorised Gemzar on 2 December 2015
Marketing authorisations
FDA — authorised 5 January 2016
- Application: ANDA204520
- Marketing authorisation holder: GLAND
- Status: approved
FDA — authorised 3 October 2019
- Application: ANDA091365
- Marketing authorisation holder: DR REDDYS LABS LTD
- Indication: Labeling
- Status: approved
FDA — authorised 3 October 2019
- Application: ANDA202485
- Marketing authorisation holder: JIANGSU HANSOH PHARM
- Indication: Labeling
- Status: approved
FDA — authorised 4 October 2019
- Application: ANDA210991
- Marketing authorisation holder: SHILPA
- Status: approved
Gemzar 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 Gemzar approved in United States?
Yes. FDA authorised it on 2 December 2015; FDA authorised it on 5 January 2016; FDA authorised it on 3 October 2019.
Who is the marketing authorisation holder for Gemzar in United States?
TEYRO LABS holds the US marketing authorisation.