FDA — authorised 10 June 1998
- Application: NDA019785
- Marketing authorisation holder: SHINE
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 Arnicare Leg Cramps in United States
FDA authorised Arnicare Leg Cramps on 10 June 1998
Marketing authorisations
FDA — authorised 23 July 1999
- Application: NDA018680
- Marketing authorisation holder: COOPERSURGICAL
- Indication: Manufacturing (CMC)
- Status: approved
FDA — authorised 22 December 2021
- Application: NDA213227
- Marketing authorisation holder: CURIUM
- Indication: Labeling
- Status: approved
FDA — authorised 1 October 2025
- Application: NDA218201
- Marketing authorisation holder: SEBELA WOMENS HLTH
- Indication: REMS
- Status: approved
The FDA approved Arnicare Leg Cramps for marketing in the United States on 2025-10-01. The marketing authorisation holder is SEBELA WOMENS HLTH. The approval was granted under the standard expedited pathway.
FDA — authorised 12 January 2026
- Application: NDA211241
- Marketing authorisation holder: SENTYNL THERAPS INC
- Indication: Type 1 - New Molecular Entity
- Status: approved
The FDA approved Arnicare Leg Cramps, a new molecular entity, for marketing in the United States on 12 January 2026. The marketing authorisation holder is SENTYNL THERAPS INC. The application was submitted under the standard expedited pathway.
FDA
- Marketing authorisation holder: SENTYNL THERAPS INC
- Status: approved
Arnicare Leg Cramps in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Pain approved in United States
Frequently asked questions
Is Arnicare Leg Cramps approved in United States?
Yes. FDA authorised it on 10 June 1998; FDA authorised it on 23 July 1999; FDA authorised it on 22 December 2021.
Who is the marketing authorisation holder for Arnicare Leg Cramps in United States?
SHINE holds the US marketing authorisation.