FDA — authorised 15 November 1968
- Application: NDA011459
- Marketing authorisation holder: PFIZER
- Local brand name: VISTARIL
- Indication: CAPSULE — ORAL
- Status: approved
🇺🇸 HYDROXYZINE PAMOATE in United States
FDA authorised HYDROXYZINE PAMOATE on 15 November 1968 · 2,013 US adverse-event reports
Marketing authorisations
FDA — authorised 14 December 1981
- Application: ANDA086183
- Marketing authorisation holder: SANDOZ
- Local brand name: HYDROXYZINE PAMOATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 14 December 1981
- Application: ANDA087479
- Marketing authorisation holder: SANDOZ
- Status: supplemented
FDA — authorised 5 March 1982
- Application: ANDA087761
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: HYDROXYZINE PAMOATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 5 March 1982
- Application: ANDA087760
- Marketing authorisation holder: IVAX SUB TEVA PHARMS
- Local brand name: HYDROXYZINE PAMOATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 1 July 1982
- Application: ANDA086705
- Marketing authorisation holder: WATSON LABS
- Local brand name: HYDROXYZINE PAMOATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 1 July 1982
- Application: ANDA086840
- Marketing authorisation holder: WATSON LABS
- Local brand name: HYDROXYZINE PAMOATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 16 August 1982
- Application: ANDA087790
- Marketing authorisation holder: WATSON LABS
- Local brand name: HYDROXYZINE PAMOATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 16 August 1982
- Application: ANDA087767
- Marketing authorisation holder: WATSON LABS
- Local brand name: HYDROXYZINE PAMOATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 5 October 1982
- Application: ANDA086728
- Marketing authorisation holder: WATSON LABS
- Local brand name: HYDROXYZINE PAMOATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 September 1983
- Application: ANDA088392
- Marketing authorisation holder: VANGARD
- Local brand name: HYDROXYZINE PAMOATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 19 September 1983
- Application: ANDA088393
- Marketing authorisation holder: VANGARD
- Local brand name: HYDROXYZINE PAMOATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 February 1984
- Application: ANDA088593
- Marketing authorisation holder: DURAMED PHARMS BARR
- Local brand name: HYDROXYZINE PAMOATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 29 February 1984
- Application: ANDA088595
- Marketing authorisation holder: DURAMED PHARMS BARR
- Local brand name: HYDROXYZINE PAMOATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 15 June 1984
- Application: ANDA088488
- Marketing authorisation holder: BARR LABS
- Status: supplemented
FDA — authorised 15 June 1984
- Application: ANDA088487
- Marketing authorisation holder: BARR LABS
- Status: supplemented
FDA — authorised 15 June 1984
- Application: ANDA088496
- Marketing authorisation holder: BARR
- Status: supplemented
FDA — authorised 4 March 1985
- Application: ANDA088713
- Marketing authorisation holder: TEVA
- Local brand name: HY-PAM "25"
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 January 1987
- Application: ANDA089033
- Marketing authorisation holder: SUPERPHARM
- Local brand name: HYDROXYZINE PAMOATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 January 1987
- Application: ANDA089031
- Marketing authorisation holder: SUPERPHARM
- Local brand name: HYDROXYZINE PAMOATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 January 1987
- Application: ANDA089032
- Marketing authorisation holder: SUPERPHARM
- Local brand name: HYDROXYZINE PAMOATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 2 September 1988
- Application: ANDA088594
- Marketing authorisation holder: DURAMED PHARMS BARR
- Local brand name: HYDROXYZINE PAMOATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 June 1991
- Application: ANDA081128
- Marketing authorisation holder: SANDOZ
- Local brand name: HYDROXYZINE PAMOATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 June 1991
- Application: ANDA081129
- Marketing authorisation holder: SANDOZ
- Local brand name: HYDROXYZINE PAMOATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 28 June 1991
- Application: ANDA081127
- Marketing authorisation holder: BEXIMCO PHARMS USA
- Local brand name: HYDROXYZINE PAMOATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 31 July 1991
- Application: ANDA081165
- Marketing authorisation holder: WATSON LABS
- Local brand name: HYDROXYZINE PAMOATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 15 July 1996
- Application: ANDA040156
- Marketing authorisation holder: IMPAX LABS INC
- Local brand name: HYDROXYZINE PAMOATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA — authorised 3 June 2013
- Application: ANDA201507
- Marketing authorisation holder: HERITAGE PHARMA
- Local brand name: HYDROXYZINE PAMOATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA086698
- Marketing authorisation holder: WATSON LABS
- Local brand name: HYDROXYZINE PAMOATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA086695
- Marketing authorisation holder: WATSON LABS
- Local brand name: HYDROXYZINE PAMOATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA086697
- Marketing authorisation holder: WATSON LABS
- Local brand name: HYDROXYZINE PAMOATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Status: approved
FDA
- Application: ANDA087656
- Marketing authorisation holder: PAR PHARM
- Local brand name: HYDROXYZINE PAMOATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA087657
- Marketing authorisation holder: PAR PHARM
- Local brand name: HYDROXYZINE PAMOATE
- Indication: CAPSULE — ORAL
- Status: approved
FDA
- Application: ANDA087658
- Marketing authorisation holder: PAR PHARM
- Local brand name: HYDROXYZINE PAMOATE
- Indication: CAPSULE — ORAL
- 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: 2,013
Most-reported reactions
- Drug Ineffective — 281 reports (13.96%)
- Completed Suicide — 275 reports (13.66%)
- Nausea — 217 reports (10.78%)
- Fatigue — 213 reports (10.58%)
- Drug Hypersensitivity — 197 reports (9.79%)
- Pain — 187 reports (9.29%)
- Anxiety — 173 reports (8.59%)
- Headache — 170 reports (8.45%)
- Pruritus — 155 reports (7.7%)
- Rash — 145 reports (7.2%)
HYDROXYZINE PAMOATE 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 HYDROXYZINE PAMOATE approved in United States?
Yes. FDA authorised it on 15 November 1968; FDA authorised it on 14 December 1981; FDA authorised it on 14 December 1981.
Who is the marketing authorisation holder for HYDROXYZINE PAMOATE in United States?
PFIZER holds the US marketing authorisation.