FDA — authorised 11 July 1996
- Application: ANDA040120
- Marketing authorisation holder: TEVA PHARMS
- Local brand name: PROCHLORPERAZINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
🇺🇸 PROCHLORPERAZINE MALEATE in United States
FDA authorised PROCHLORPERAZINE MALEATE on 11 July 1996 · 7,083 US adverse-event reports
Marketing authorisations
FDA — authorised 19 July 1996
- Application: ANDA040101
- Marketing authorisation holder: CHARTWELL RX
- Local brand name: PROCHLORPERAZINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 May 1997
- Application: ANDA040207
- Marketing authorisation holder: DURAMED PHARMS BARR
- Local brand name: PROCHLORPERAZINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 February 1998
- Application: ANDA040268
- Marketing authorisation holder: JUBILANT CADISTA
- Local brand name: PROCOMP
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 13 June 2022
- Application: ANDA216202
- Marketing authorisation holder: NOVITIUM PHARMA
- Local brand name: PROCHLORPERAZINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 August 2022
- Application: ANDA216495
- Marketing authorisation holder: ZYDUS LIFESCIENCES
- Local brand name: PROCHLORPERAZINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 March 2023
- Application: ANDA216595
- Marketing authorisation holder: GLENMARK PHARMS LTD
- Local brand name: PROCHLORPERAZINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 April 2023
- Application: ANDA217478
- Marketing authorisation holder: BIONPHARMA
- Local brand name: PROCHLORPERAZINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 April 2023
- Application: ANDA216598
- Marketing authorisation holder: AMNEAL
- Local brand name: PROCHLORPERAZINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 May 2024
- Application: ANDA218515
- Marketing authorisation holder: AJANTA PHARMA LTD
- Local brand name: PROCHLORPERAZINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 30 September 2024
- Application: ANDA218912
- Marketing authorisation holder: LEADING
- Local brand name: PROCHLORPERAZINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 19 May 2025
- Application: ANDA217847
- Marketing authorisation holder: DR REDDYS LABS SA
- Local brand name: PROCHLORPERAZINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 8 September 2025
- Application: ANDA218734
- Marketing authorisation holder: AUROBINDO PHARMA LTD
- Local brand name: PROCHLORPERAZINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA089486
- Marketing authorisation holder: DURAMED PHARMS BARR
- Local brand name: PROCHLORPERAZINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA089484
- Marketing authorisation holder: DURAMED PHARMS BARR
- Local brand name: PROCHLORPERAZINE MALEATE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA089485
- Marketing authorisation holder: DURAMED PHARMS BARR
- Local brand name: PROCHLORPERAZINE MALEATE
- 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: 7,083
Most-reported reactions
- Nausea — 1,286 reports (18.16%)
- Fatigue — 1,254 reports (17.7%)
- Diarrhoea — 948 reports (13.38%)
- Death — 676 reports (9.54%)
- Vomiting — 642 reports (9.06%)
- Asthenia — 535 reports (7.55%)
- Decreased Appetite — 513 reports (7.24%)
- Constipation — 417 reports (5.89%)
- Off Label Use — 416 reports (5.87%)
- Pain — 396 reports (5.59%)
PROCHLORPERAZINE MALEATE 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 PROCHLORPERAZINE MALEATE approved in United States?
Yes. FDA authorised it on 11 July 1996; FDA authorised it on 19 July 1996; FDA authorised it on 1 May 1997.
Who is the marketing authorisation holder for PROCHLORPERAZINE MALEATE in United States?
TEVA PHARMS holds the US marketing authorisation.