FDA — authorised 28 July 1988
- Status: approved
🇺🇸 Voltaren in United States
FDA authorised Voltaren on 28 July 1988
Marketing authorisations
FDA — authorised 24 August 2021
- Application: ANDA204132
- Marketing authorisation holder: LUPIN LTD
- Indication: Labeling
- Status: approved
FDA — authorised 4 March 2022
- Application: ANDA215375
- Marketing authorisation holder: ANNORA PHARMA
- Status: approved
FDA — authorised 21 September 2022
- Application: ANDA208021
- Marketing authorisation holder: LUPIN PHARMS
- Status: approved
FDA — authorised 14 December 2022
- Application: ANDA216635
- Marketing authorisation holder: ALKEM LABS LTD
- Indication: Labeling
- Status: approved
FDA — authorised 9 November 2023
- Application: ANDA215787
- Marketing authorisation holder: SENORES PHARMS
- Indication: Manufacturing (CMC)
- Status: approved
Voltaren 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 Voltaren approved in United States?
Yes. FDA authorised it on 28 July 1988; FDA authorised it on 24 August 2021; FDA authorised it on 4 March 2022.
Who is the marketing authorisation holder for Voltaren in United States?
Hisamitsu Pharmaceutical Co., Inc is the originator. The local marketing authorisation holder may differ — check the official source linked above.