FDA — authorised 30 October 2015
- Application: ANDA090278
- Marketing authorisation holder: SUN PHARM
- Indication: Labeling
- Status: approved
🇺🇸 Topamax in United States
FDA authorised Topamax on 30 October 2015
Marketing authorisations
FDA — authorised 8 March 2023
- Application: ANDA076343
- Marketing authorisation holder: CIPLA LTD
- Indication: Labeling
- Status: approved
FDA — authorised 17 July 2023
- Application: ANDA215414
- Marketing authorisation holder: ASCENT PHARMS INC
- Indication: Labeling
- Status: approved
FDA — authorised 27 May 2025
- Application: ANDA216683
- Marketing authorisation holder: RUBICON RESEARCH
- Status: approved
FDA — authorised 18 March 2026
- Application: ANDA218482
- Marketing authorisation holder: ALKEM LABS LTD
- Indication: Labeling
- Status: approved
ALKEM LABS LTD received marketing authorisation from the FDA for Topamax on 18 March 2026. This authorisation was granted under the standard expedited pathway. The approved indication for Topamax is listed in the labelling.
Topamax in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is Topamax approved in United States?
Yes. FDA authorised it on 30 October 2015; FDA authorised it on 8 March 2023; FDA authorised it on 17 July 2023.
Who is the marketing authorisation holder for Topamax in United States?
SUN PHARM holds the US marketing authorisation.