FDA — authorised 30 September 1997
- Application: NDA020646
- Marketing authorisation holder: CEPHALON
- Status: supplemented
🇺🇸 TIAGABINE HYDROCHLORIDE in United States
FDA authorised TIAGABINE HYDROCHLORIDE on 30 September 1997 · 110 US adverse-event reports
Marketing authorisations
FDA — authorised 4 November 2011
- Application: ANDA077555
- Marketing authorisation holder: SUN PHARM INDS
- Local brand name: TIAGABINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 October 2017
- Application: ANDA206857
- Marketing authorisation holder: WILSHIRE PHARMS INC
- Local brand name: TIAGABINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 December 2017
- Application: ANDA208181
- Marketing authorisation holder: AMNEAL PHARMS CO
- Local brand name: TIAGABINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 16 November 2021
- Application: ANDA214816
- Marketing authorisation holder: MSN
- Local brand name: TIAGABINE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 110
Most-reported reactions
- Encephalopathy — 16 reports (14.55%)
- Off Label Use — 16 reports (14.55%)
- Myoclonus — 14 reports (12.73%)
- Drug Ineffective — 12 reports (10.91%)
- Convulsion — 10 reports (9.09%)
- Dizziness — 10 reports (9.09%)
- Feeling Abnormal — 10 reports (9.09%)
- Somnolence — 8 reports (7.27%)
- Anxiety — 7 reports (6.36%)
- Drug Interaction — 7 reports (6.36%)
TIAGABINE 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 TIAGABINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 30 September 1997; FDA authorised it on 4 November 2011; FDA authorised it on 13 October 2017.
Who is the marketing authorisation holder for TIAGABINE HYDROCHLORIDE in United States?
CEPHALON holds the US marketing authorisation.