FDA — authorised 23 August 1995
- Application: ANDA074317
- Marketing authorisation holder: WATSON LABS
- Local brand name: HYDROMORPHONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 HYDROMORPHONE HYDROCHLORIDE in United States
FDA authorised HYDROMORPHONE HYDROCHLORIDE on 23 August 1995 · 18,056 US adverse-event reports
Marketing authorisations
FDA — authorised 19 June 1997
- Application: ANDA074598
- Marketing authorisation holder: HOSPIRA
- Local brand name: HYDROMORPHONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 July 1998
- Application: ANDA074597
- Marketing authorisation holder: HIKMA
- Local brand name: HYDROMORPHONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 29 July 1998
- Application: ANDA074653
- Marketing authorisation holder: HIKMA
- Local brand name: HYDROMORPHONE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 24 September 2004
- Application: NDA021044
- Marketing authorisation holder: PURDUE PHARMA LP
- Local brand name: PALLADONE
- Indication: CAPSULE, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 23 December 2004
- Application: ANDA076855
- Marketing authorisation holder: SPECGX LLC
- Local brand name: HYDROMORPHONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 November 2005
- Application: ANDA077311
- Marketing authorisation holder: NESHER PHARMS
- Local brand name: HYDROMORPHONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 17 June 2008
- Application: ANDA078591
- Marketing authorisation holder: HOSPIRA INC
- Local brand name: HYDROMORPHONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 9 December 2009
- Application: ANDA078439
- Marketing authorisation holder: LANNETT
- Local brand name: HYDROMORPHONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 9 December 2009
- Application: ANDA077471
- Marketing authorisation holder: GENUS
- Local brand name: HYDROMORPHONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 1 March 2010
- Application: NDA021217
- Marketing authorisation holder: SPECGX LLC
- Local brand name: EXALGO
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 14 April 2010
- Application: ANDA078261
- Marketing authorisation holder: RISING
- Local brand name: HYDROMORPHONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 14 April 2010
- Application: ANDA078228
- Marketing authorisation holder: RISING
- Local brand name: HYDROMORPHONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 1 December 2011
- Application: NDA200403
- Marketing authorisation holder: HOSPIRA INC
- Local brand name: HYDROMORPHONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 12 May 2014
- Application: ANDA202144
- Marketing authorisation holder: ACTAVIS LABS FL INC
- Local brand name: HYDROMORPHONE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 13 May 2016
- Application: ANDA205814
- Marketing authorisation holder: AUROLIFE PHARMA LLC
- Local brand name: HYDROMORPHONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 7 July 2016
- Application: ANDA205629
- Marketing authorisation holder: OSMOTICA PHARM US
- Local brand name: HYDROMORPHONE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 27 October 2017
- Application: ANDA210176
- Marketing authorisation holder: ASCENT PHARMS INC
- Local brand name: HYDROMORPHONE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 17 January 2018
- Application: ANDA210506
- Marketing authorisation holder: ASCENT PHARMS INC
- Local brand name: HYDROMORPHONE HYDROCHLORIDE
- Indication: TABLET — ORAL
- Status: approved
FDA — authorised 27 April 2018
- Application: ANDA202159
- Marketing authorisation holder: HIKMA
- Local brand name: HYDROMORPHONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 22 April 2020
- Application: ANDA207108
- Marketing authorisation holder: GENUS
- Local brand name: HYDROMORPHONE HYDROCHLORIDE
- Indication: SOLUTION — ORAL
- Status: approved
FDA — authorised 23 September 2020
- Application: ANDA212133
- Marketing authorisation holder: ASCENT PHARMS INC
- Local brand name: HYDROMORPHONE HYDROCHLORIDE
- Indication: TABLET, EXTENDED RELEASE — ORAL
- Status: approved
FDA — authorised 14 December 2023
- Application: NDA217812
- Marketing authorisation holder: HIKMA
- Local brand name: HYDROMORPHONE HYDROCHLORIDE
- Indication: SOLUTION — INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
- Status: approved
FDA — authorised 9 February 2024
- Application: ANDA216899
- Marketing authorisation holder: HIKMA
- Local brand name: HYDROMORPHONE HYDROCHLORIDE
- Indication: INJECTABLE — INJECTION
- 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: 18,056
Most-reported reactions
- Drug Dependence — 2,773 reports (15.36%)
- Pain — 2,405 reports (13.32%)
- Drug Ineffective — 2,010 reports (11.13%)
- Overdose — 1,845 reports (10.22%)
- Nausea — 1,731 reports (9.59%)
- Off Label Use — 1,724 reports (9.55%)
- Drug Hypersensitivity — 1,528 reports (8.46%)
- Vomiting — 1,415 reports (7.84%)
- Headache — 1,376 reports (7.62%)
- Fatigue — 1,249 reports (6.92%)
HYDROMORPHONE 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 HYDROMORPHONE HYDROCHLORIDE approved in United States?
Yes. FDA authorised it on 23 August 1995; FDA authorised it on 19 June 1997; FDA authorised it on 29 July 1998.
Who is the marketing authorisation holder for HYDROMORPHONE HYDROCHLORIDE in United States?
WATSON LABS holds the US marketing authorisation.