Data updated: Mar 10, 2026
OXYCODONE AND ACETAMINOPHEN
ACETAMINOPHEN
Approved 1981-11-02
42
Indications
--
Phase 3 Trials
44
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1981-11-02
- Routes
- ORAL
- Dosage Forms
- TABLET, CAPSULE, SOLUTION
Companies
Dr. Reddy's ELITE LABS INC Teva Sun Pharma WES PHARMA INC NESHER PHARMS ABHAI LLC VINTAGE PHARMS DURAMED PHARMS BARR VINTAGE PHARMS LLC WATSON LABS MIKART HALSEY PH HEALTH LANNETT CO INC MUTUAL PHARM SPECGX LLC AMNEAL PHARMS NY ALVOGEN NOVEL LABS INC MALLINCKRODT AMNEAL PHARMS RHODES PHARMS AUROLIFE PHARMA LLC EPIC PHARMA LLC CHARTWELL SANALUZ SANKALP LIFECARE ASCENT PHARMS INC GRANULES
Website: ↗
OXYCODONE AND ACETAMINOPHEN Approval History
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What OXYCODONE AND ACETAMINOPHEN Treats
42 FDA approvalsOriginally approved for its first indication in 1981 . Covers 42 distinct patient populations.
- Other (42)
Other
(42 approvals)- • Approved indication (Nov 1981)
- • Approved indication (May 1989)
- • Approved indication (Jul 1996)
- • Approved indication (Oct 1997)
- • Approved indication (Jan 1998)
- • Approved indication (Jun 1998)Letter
- • Approved indication (Aug 1998)Label Letter
- • Approved indication (Dec 1998)Label Letter
- • Approved indication (Mar 1999)Letter
- • Approved indication (Mar 1999)Letter
- • Approved indication (Dec 1999)Label Letter
- • Approved indication (Oct 2000)Letter
- • Approved indication (Dec 2000)Letter
- • Approved indication (Sep 2003)
- • Approved indication (Jun 2004)
- • Approved indication (Dec 2005)
- • Approved indication (Apr 2006)
- • Approved indication (Apr 2006)
- • Approved indication (May 2006)
- • Approved indication (Sep 2006)
- • Approved indication (Nov 2007)
- • Approved indication (Oct 2008)
- • Approved indication (Apr 2012)
- • Approved indication (Jul 2012)
- • Approved indication (Apr 2013)
- • Approved indication (Jul 2013)
- • Approved indication (Jul 2013)
- • Approved indication (Dec 2013)
- • Approved indication (Aug 2014)Letter
- • Approved indication (Dec 2016)
- • Approved indication (Feb 2017)
- • Approved indication (Mar 2017)
- • Approved indication (Sep 2017)Letter
- • Approved indication (Dec 2017)
- • Approved indication (Feb 2018)
- • Approved indication (Mar 2018)
- • Approved indication (Jul 2018)
- • Approved indication (Nov 2018)Letter
- • Approved indication (Dec 2018)
- • Approved indication (Aug 2019)
- • Approved indication (Oct 2019)
- • Approved indication (Aug 2021)
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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.
OXYCODONE AND ACETAMINOPHEN FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.