Data updated: Mar 10, 2026
MORPHINE SULFATE
MORPHINE SULFATE
Approved 1988-05-11
55
Indications
--
Phase 3 Trials
1
Priority Reviews
37
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1988-05-11
- Routes
- ORAL, INJECTION, INTRAMUSCULAR, INTRAVENOUS
- Dosage Forms
- SOLUTION, CAPSULE, EXTENDED RELEASE, INJECTABLE, TABLET, TABLET, EXTENDED RELEASE
Companies
CHARTWELL MOLECULAR ANDA REPOSITORY ANI PHARMS SPECGX LLC Hikma WATSON LABS Pfizer TRIS PHARMA INC PHARM ASSOC INGENUS PHARMS NJ Sun Pharma PADAGIS US NOVEL LABS INC RHODES PHARMS Fresenius Kabi ICU MEDICAL INC Teva UPSHER SMITH LABS DAVA PHARMS INC NESHER PHARMS STRIDES PHARMA INTL SANKALP LIFECARE WINDER LABS LLC EPIC PHARMA LLC IMPAX LABS INC VISTAPHARM INTL MEDICATION SYS Dr. Reddy's ALKEM LABS LTD RISING
Active Ingredient: MORPHINE SULFATE
Website: ↗
MORPHINE SULFATE Approval History
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What MORPHINE SULFATE Treats
55 FDA approvalsOriginally approved for its first indication in 1988 . Covers 55 distinct patient populations.
- Other (55)
Other
(55 approvals)- • Approved indication (May 1988)
- • Approved indication (Sep 1991)
- • Approved indication (Sep 1992)
- • Approved indication (Oct 1992)
- • Approved indication (Jul 1996)
- • Approved indication (Jul 1998)Label Letter
- • Approved indication (Jul 1998)Label Letter
- • Approved indication (Oct 1998)Letter
- • Approved indication (Jan 2000)Letter
- • Approved indication (Jan 2001)Letter
- • Approved indication (Jul 2003)
- • Approved indication (Jul 2003)
- • Approved indication (May 2004)
- • Approved indication (Sep 2007)
- • Approved indication (Mar 2008)Label Letter
- • Approved indication (Jan 2010) PriorityLabel Letter
- • Approved indication (Jun 2011)Label Letter
- • Approved indication (Jul 2011)
- • Approved indication (Oct 2011)
- • Approved indication (Nov 2011)
- • Approved indication (Nov 2011)Label Letter
- • Approved indication (Jan 2012)
- • Approved indication (May 2012)
- • Approved indication (Aug 2012)
- • Approved indication (Jan 2013)
- • Approved indication (Jun 2013)
- • Approved indication (Oct 2013)Label Letter
- • Approved indication (Feb 2014)
- • Approved indication (Dec 2014)Letter
- • Approved indication (Apr 2015)Label Letter
- • Approved indication (May 2015)Letter
- • Approved indication (May 2015)Letter
- • Approved indication (Oct 2015)Letter
- • Approved indication (Nov 2015)Label Letter
- • Approved indication (Dec 2015)Letter
- • Approved indication (Apr 2016)
- • Approved indication (May 2016)
- • Approved indication (Jun 2016)
- • Approved indication (Jul 2016)
- • Approved indication (Aug 2016)
- • Approved indication (Oct 2016)
- • Approved indication (Nov 2016)
- • Approved indication (Jun 2017)Letter
- • Approved indication (Jul 2017)
- • Approved indication (Apr 2018)Letter
- • Approved indication (Jul 2019)Letter
- • Approved indication (Dec 2020)Letter
- • Approved indication (Feb 2021)
- • Approved indication (Apr 2021)Label Letter
- • Approved indication (Jun 2021)Label Letter
- • Approved indication (Aug 2021)
- • Approved indication (Jan 2022)
- • Approved indication (Feb 2022)
- • Approved indication (Jan 2023)Letter
- • Approved indication (Aug 2023)
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MORPHINE SULFATE FDA Label Details
ProMORPHINE SULFATE Patents & Exclusivity
Latest Patent: Mar 2034
Patents (100 active)
Source: FDA Orange Book
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.