FDA — authorised 7 July 1998
- Application: ANDA074862
- Marketing authorisation holder: RHODES PHARMS
- Status: supplemented
🇺🇸 MORPHINE SULFATE in United States
FDA authorised MORPHINE SULFATE on 7 July 1998 · 87,211 US adverse-event reports
Marketing authorisations
FDA — authorised 15 July 2011
- Application: ANDA202348
- Marketing authorisation holder: SPECGX LLC
- Status: approved
FDA — authorised 28 September 2012
- Application: ANDA074769
- Marketing authorisation holder: RHODES PHARMS
- Indication: Labeling
- Status: approved
FDA — authorised 16 January 2013
- Application: ANDA079040
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Indication: REMS
- Status: approved
FDA — authorised 30 October 2013
- Application: NDA204223
- Marketing authorisation holder: FRESENIUS KABI USA
- Status: supplemented
FDA — authorised 6 April 2015
- Application: ANDA203849
- Marketing authorisation holder: ACTAVIS ELIZABETH
- Status: supplemented
FDA — authorised 21 May 2015
- Application: ANDA205758
- Marketing authorisation holder: HIKMA
- Status: approved
FDA — authorised 30 September 2016
- Application: ANDA200411
- Marketing authorisation holder: IMPAX LABS INC
- Indication: REMS
- 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: 87,211
Most-reported reactions
- Drug Dependence — 20,539 reports (23.55%)
- Overdose — 12,558 reports (14.4%)
- Pain — 11,408 reports (13.08%)
- Drug Hypersensitivity — 10,461 reports (12%)
- Emotional Distress — 6,938 reports (7.96%)
- Death — 5,801 reports (6.65%)
- Nausea — 4,985 reports (5.72%)
- Dependence — 4,920 reports (5.64%)
- Drug Ineffective — 4,816 reports (5.52%)
- Drug Withdrawal Syndrome — 4,785 reports (5.49%)
MORPHINE SULFATE 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 MORPHINE SULFATE approved in United States?
Yes. FDA authorised it on 7 July 1998; FDA authorised it on 15 July 2011; FDA authorised it on 28 September 2012.
Who is the marketing authorisation holder for MORPHINE SULFATE in United States?
RHODES PHARMS holds the US marketing authorisation.