FDA — authorised 19 October 1984
- Application: NDA019090
- Marketing authorisation holder: PAI HOLDINGS PHARM
- Local brand name: ZANTAC
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Zantac in United States
FDA authorised Zantac on 19 October 1984
Marketing authorisations
FDA — authorised 30 December 1988
- Application: NDA019675
- Marketing authorisation holder: GLAXO GRP LTD
- Local brand name: ZANTAC
- Indication: SYRUP — ORAL
- Status: approved
FDA — authorised 29 November 2000
- Application: ANDA075742
- Marketing authorisation holder: DR REDDYS LABS LTD
- Status: approved
FDA — authorised 20 March 2008
- Application: ANDA077824
- Marketing authorisation holder: AMNEAL PHARMS NY
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 18 January 2012
- Application: ANDA078192
- Marketing authorisation holder: DR REDDYS LABS LTD
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 20 August 2018
- Application: ANDA210243
- Marketing authorisation holder: GRANULES
- Status: approved
FDA — authorised 7 August 2019
- Application: ANDA211289
- Marketing authorisation holder: VKT PHARMA
- Indication: Manufacturing (CMC)
- Status: approved
Zantac 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 Zantac approved in United States?
Yes. FDA authorised it on 19 October 1984; FDA authorised it on 30 December 1988; FDA authorised it on 29 November 2000.
Who is the marketing authorisation holder for Zantac in United States?
PAI HOLDINGS PHARM holds the US marketing authorisation.