FDA — authorised 3 August 2015
- Application: ANDA202645
- Marketing authorisation holder: ACTAVIS LABS FL INC
- Local brand name: PALIPERIDONE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
🇺🇸 PALIPERIDONE in United States
FDA authorised PALIPERIDONE on 3 August 2015 · 5,648 US adverse-event reports
Marketing authorisations
FDA — authorised 24 September 2015
- Application: ANDA203802
- Marketing authorisation holder: RK PHARMA
- Local brand name: PALIPERIDONE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 6 April 2018
- Application: ANDA205618
- Marketing authorisation holder: SUN PHARM
- Local brand name: PALIPERIDONE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 12 June 2019
- Application: ANDA204452
- Marketing authorisation holder: INVENTIA
- Local brand name: PALIPERIDONE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 23 September 2019
- Application: ANDA204707
- Marketing authorisation holder: AMNEAL PHARMS
- Local brand name: PALIPERIDONE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 29 October 2020
- Application: ANDA212807
- Marketing authorisation holder: CSPC OUYI
- Local brand name: PALIPERIDONE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 29 June 2022
- Application: ANDA208643
- Marketing authorisation holder: LUPIN
- Local brand name: PALIPERIDONE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 23 August 2023
- Application: ANDA216174
- Marketing authorisation holder: ASCENT PHARMS INC
- Local brand name: PALIPERIDONE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 26 June 2024
- Application: ANDA218514
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: PALIPERIDONE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 26 September 2024
- Application: ANDA218330
- Marketing authorisation holder: ALEMBIC
- Local brand name: PALIPERIDONE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 8 October 2024
- Application: ANDA217445
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: PALIPERIDONE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 19 February 2025
- Application: ANDA205559
- Marketing authorisation holder: DR REDDYS
- Local brand name: PALIPERIDONE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 4 September 2025
- Application: ANDA218755
- Marketing authorisation holder: ESKAYEF
- Local brand name: PALIPERIDONE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 26 January 2026
- Application: ANDA203279
- Marketing authorisation holder: APOTEX
- Local brand name: PALIPERIDONE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 7 May 2026
- Application: ANDA205402
- Marketing authorisation holder: I3 PHARMS
- Local brand name: PALIPERIDONE
- Indication: TABLET, EXTENDED RELEASE — 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: 5,648
Most-reported reactions
- Drug Ineffective — 1,114 reports (19.72%)
- Schizophrenia — 580 reports (10.27%)
- Sedation — 580 reports (10.27%)
- Suicide Attempt — 550 reports (9.74%)
- Dyskinesia — 549 reports (9.72%)
- Dystonia — 525 reports (9.3%)
- Off Label Use — 461 reports (8.16%)
- Hospitalisation — 449 reports (7.95%)
- Sexual Dysfunction — 424 reports (7.51%)
- Condition Aggravated — 416 reports (7.37%)
PALIPERIDONE 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 PALIPERIDONE approved in United States?
Yes. FDA authorised it on 3 August 2015; FDA authorised it on 24 September 2015; FDA authorised it on 6 April 2018.
Who is the marketing authorisation holder for PALIPERIDONE in United States?
ACTAVIS LABS FL INC holds the US marketing authorisation.