FDA — authorised 27 July 1983
- Application: NDA017854
- Marketing authorisation holder: ANI PHARMS
- Indication: Manufacturing (CMC)
- Status: approved
🇺🇸 METOCLOPRAMIDE HYDROCHLORIDE in United States
FDA authorised METOCLOPRAMIDE HYDROCHLORIDE on 27 July 1983 · 7,776 US adverse-event reports
Marketing authorisations
FDA — authorised 29 July 1985
- Application: ANDA070184
- Marketing authorisation holder: TEVA
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 October 1985
- Application: ANDA070632
- Marketing authorisation holder: QUANTUM PHARMICS
- Local brand name: CLOPRA-"YELLOW"
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 22 January 1986
- Application: ANDA070511
- Marketing authorisation holder: WATSON LABS
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 24 January 1986
- Application: ANDA070293
- Marketing authorisation holder: LYPHOMED
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 16 September 1986
- Application: ANDA070342
- Marketing authorisation holder: PAR PHARM
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 10 February 1987
- Application: ANDA070660
- Marketing authorisation holder: MUTUAL PHARM
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 2 March 1987
- Application: ANDA070622
- Marketing authorisation holder: SMITH AND NEPHEW
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 10 July 1987
- Application: ANDA070819
- Marketing authorisation holder: TEVA
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 3 February 1988
- Application: ANDA071250
- Marketing authorisation holder: IMPAX LABS INC
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 18 August 1988
- Application: ANDA071340
- Marketing authorisation holder: ACTAVIS MID ATLANTIC
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 7 November 1988
- Application: ANDA070847
- Marketing authorisation holder: HOSPIRA
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 5 December 1988
- Application: ANDA072038
- Marketing authorisation holder: ROXANE
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 3 March 1989
- Application: ANDA071291
- Marketing authorisation holder: HOSPIRA
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 May 1989
- Application: ANDA070949
- Marketing authorisation holder: MORTON GROVE
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 22 June 1989
- Application: ANDA070506
- Marketing authorisation holder: HOSPIRA
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 23 June 1989
- Application: ANDA070505
- Marketing authorisation holder: HOSPIRA
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 30 January 1990
- Application: ANDA072215
- Marketing authorisation holder: AIPING PHARM INC
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 May 1991
- Application: ANDA072639
- Marketing authorisation holder: CLONMEL
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 28 May 1991
- Application: ANDA072744
- Marketing authorisation holder: GENUS
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 30 January 1992
- Application: ANDA072995
- Marketing authorisation holder: ROXANE
- Local brand name: METOCLOPRAMIDE INTENSOL
- Indication: CONCENTRATE — ORAL
- Status: approved
FDA — authorised 27 October 1992
- Application: ANDA073680
- Marketing authorisation holder: CHARTWELL MOLECULAR
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 28 April 1993
- Application: ANDA071536
- Marketing authorisation holder: SUN PHARM INDUSTRIES
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 15 June 1993
- Application: ANDA072801
- Marketing authorisation holder: TEVA
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 25 June 1993
- Application: ANDA071402
- Marketing authorisation holder: ANI PHARMS
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 30 June 1993
- Application: ANDA071315
- Marketing authorisation holder: TEVA
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 31 October 1997
- Application: ANDA074703
- Marketing authorisation holder: PHARMOBEDIENT CNSLTG
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 26 January 2001
- Application: ANDA075051
- Marketing authorisation holder: VISTAPHARM LLC
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 30 November 2007
- Application: ANDA078374
- Marketing authorisation holder: NORTHSTAR HLTHCARE
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 12 June 2008
- Application: ANDA078807
- Marketing authorisation holder: IPCA LABS LTD
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 4 September 2009
- Application: NDA022246
- Marketing authorisation holder: SALIX PHARMS
- Local brand name: METOZOLV ODT
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 20 December 2013
- Application: ANDA204756
- Marketing authorisation holder: AVET LIFESCIENCES
- Status: approved
FDA — authorised 15 August 2014
- Application: ANDA202191
- Marketing authorisation holder: NOVEL LABS INC
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: TABLET, ORALLY DISINTEGRATING — ORAL
- Status: approved
FDA — authorised 30 October 2019
- Application: ANDA091392
- Marketing authorisation holder: FRESENIUS KABI USA
- Indication: Labeling
- Status: approved
FDA — authorised 19 June 2020
- Application: NDA209388
- Marketing authorisation holder: QOL MEDCL
- Local brand name: GIMOTI
- Indication: SPRAY, METERED — NASAL
- Status: approved
FDA
- Application: ANDA070671
- Marketing authorisation holder: QUAD PHARMS
- Local brand name: METOCLOPRAMIDE HCL
- Indication: Injectable — Injection
- Status: approved
FDA
- Application: ANDA070850
- Marketing authorisation holder: SANDOZ
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA072384
- Marketing authorisation holder: QUANTUM PHARMICS
- Local brand name: CLOPRA
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070623
- Marketing authorisation holder: SMITH AND NEPHEW
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA070294
- Marketing authorisation holder: QUANTUM PHARMICS
- Local brand name: CLOPRA
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA071665
- Marketing authorisation holder: PACO
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA
- Application: ANDA070645
- Marketing authorisation holder: WATSON LABS
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070339
- Marketing authorisation holder: USL PHARMA
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070363
- Marketing authorisation holder: WATSON LABS
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA072155
- Marketing authorisation holder: BEDFORD
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA070106
- Marketing authorisation holder: KING PHARMS
- Local brand name: MAXOLON
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA070453
- Marketing authorisation holder: WATSON LABS
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA
- Application: ANDA072244
- Marketing authorisation holder: BEDFORD
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA
- Application: ANDA072247
- Marketing authorisation holder: BEDFORD
- Local brand name: METOCLOPRAMIDE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- 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: 7,776
Most-reported reactions
- Tardive Dyskinesia — 2,433 reports (31.29%)
- Extrapyramidal Disorder — 1,092 reports (14.04%)
- Nausea — 822 reports (10.57%)
- Incorrect Drug Administration Duration — 699 reports (8.99%)
- Off Label Use — 548 reports (7.05%)
- Diarrhoea — 511 reports (6.57%)
- Vomiting — 493 reports (6.34%)
- Nervous System Disorder — 421 reports (5.41%)
- Pyrexia — 379 reports (4.87%)
- Drug Ineffective — 378 reports (4.86%)
METOCLOPRAMIDE 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 METOCLOPRAMIDE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 27 July 1983; FDA authorised it on 29 July 1985; FDA authorised it on 28 October 1985.
Who is the marketing authorisation holder for METOCLOPRAMIDE HYDROCHLORIDE in United States?
ANI PHARMS holds the US marketing authorisation.