FDA — authorised 7 February 2018
- Application: ANDA207567
- Marketing authorisation holder: WATSON LABS TEVA
- Local brand name: TRIENTINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 TRIENTINE HYDROCHLORIDE in United States
FDA authorised TRIENTINE HYDROCHLORIDE on 7 February 2018 · 37 US adverse-event reports
Marketing authorisations
FDA — authorised 16 January 2019
- Application: ANDA211251
- Marketing authorisation holder: NAVINTA LLC
- Local brand name: TRIENTINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 26 April 2019
- Application: ANDA211554
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: TRIENTINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 May 2019
- Application: ANDA211134
- Marketing authorisation holder: MSN
- Local brand name: TRIENTINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 3 July 2019
- Application: ANDA211076
- Marketing authorisation holder: DR REDDYS
- Local brand name: TRIENTINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 16 September 2019
- Application: ANDA209415
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: TRIENTINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 25 September 2019
- Application: ANDA210096
- Marketing authorisation holder: PH HEALTH
- Local brand name: TRIENTINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 21 October 2019
- Application: ANDA209731
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: CLOVIQUE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 20 February 2020
- Application: ANDA212238
- Marketing authorisation holder: RISING
- Local brand name: TRIENTINE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 30 August 2021
- Application: ANDA212929
- Marketing authorisation holder: ACCORD HLTHCARE
- Local brand name: TRIENTINE HYDROCHLORIDE
- Indication: CAPSULE — 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: 37
Most-reported reactions
- Drug Ineffective — 7 reports (18.92%)
- Enteritis — 7 reports (18.92%)
- Tremor — 4 reports (10.81%)
- Anxiety — 3 reports (8.11%)
- Cognitive Disorder — 3 reports (8.11%)
- Condition Aggravated — 3 reports (8.11%)
- Dyskinesia — 3 reports (8.11%)
- Fatigue — 3 reports (8.11%)
- Abdominal Pain — 2 reports (5.41%)
- Acute Kidney Injury — 2 reports (5.41%)
TRIENTINE 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 TRIENTINE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 7 February 2018; FDA authorised it on 16 January 2019; FDA authorised it on 26 April 2019.
Who is the marketing authorisation holder for TRIENTINE HYDROCHLORIDE in United States?
WATSON LABS TEVA holds the US marketing authorisation.