FDA — authorised 25 August 2011
- Application: ANDA091260
- Marketing authorisation holder: APOTEX INC
- Local brand name: CEVIMELINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 CEVIMELINE HYDROCHLORIDE in United States
FDA authorised CEVIMELINE HYDROCHLORIDE on 25 August 2011
Marketing authorisations
FDA — authorised 8 July 2013
- Application: ANDA091591
- Marketing authorisation holder: HIKMA
- Local brand name: CEVIMELINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 4 June 2014
- Application: ANDA203775
- Marketing authorisation holder: RISING
- Local brand name: CEVIMELINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 December 2016
- Application: ANDA204746
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: CEVIMELINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 6 April 2023
- Application: ANDA216682
- Marketing authorisation holder: RUBICON RESEARCH
- Local brand name: CEVIMELINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 8 November 2023
- Application: ANDA218290
- Marketing authorisation holder: BIONPHARMA
- Local brand name: CEVIMELINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 20 September 2024
- Application: ANDA206808
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: CEVIMELINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 11 March 2026
- Application: ANDA220267
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: CEVIMELINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Status: approved
CEVIMELINE HYDROCHLORIDE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is CEVIMELINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 25 August 2011; FDA authorised it on 8 July 2013; FDA authorised it on 4 June 2014.
Who is the marketing authorisation holder for CEVIMELINE HYDROCHLORIDE in United States?
APOTEX INC holds the US marketing authorisation.