FDA — authorised 2 March 2012
- Application: ANDA077561
- Marketing authorisation holder: APOTEX
- Local brand name: ZIPRASIDONE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 ZIPRASIDONE HYDROCHLORIDE in United States
FDA authorised ZIPRASIDONE HYDROCHLORIDE on 2 March 2012 · 3,792 US adverse-event reports
Marketing authorisations
FDA — authorised 2 March 2012
- Application: ANDA077565
- Marketing authorisation holder: DR REDDYS LABS INC
- Local brand name: ZIPRASIDONE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 March 2012
- Application: ANDA077560
- Marketing authorisation holder: LUPIN PHARMS
- Local brand name: ZIPRASIDONE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 1 June 2012
- Application: ANDA077562
- Marketing authorisation holder: SANDOZ INC
- Local brand name: ZIPRASIDONE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 5 September 2012
- Application: ANDA090348
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: ZIPRASIDONE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 27 December 2016
- Application: ANDA204117
- Marketing authorisation holder: AUROBINDO PHARMA
- Local brand name: ZIPRASIDONE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 17 February 2017
- Application: ANDA204375
- Marketing authorisation holder: MACLEODS PHARMS LTD
- Local brand name: ZIPRASIDONE HYDROCHLORIDE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 22 August 2017
- Application: ANDA208988
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: ZIPRASIDONE 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: 3,792
Most-reported reactions
- Drug Ineffective — 522 reports (13.77%)
- Suicide Attempt — 427 reports (11.26%)
- Sedation — 392 reports (10.34%)
- Dyskinesia — 380 reports (10.02%)
- Sexual Dysfunction — 378 reports (9.97%)
- Dystonia — 372 reports (9.81%)
- Blood Prolactin Abnormal — 366 reports (9.65%)
- Anosognosia — 320 reports (8.44%)
- Blood Glucose Increased — 320 reports (8.44%)
- Metabolic Disorder — 315 reports (8.31%)
ZIPRASIDONE 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 ZIPRASIDONE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 2 March 2012; FDA authorised it on 2 March 2012; FDA authorised it on 2 March 2012.
Who is the marketing authorisation holder for ZIPRASIDONE HYDROCHLORIDE in United States?
APOTEX holds the US marketing authorisation.