Data updated: Mar 10, 2026
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ACETAMINOPHEN
Approved 1984-12-21
89
Indications
--
Phase 3 Trials
41
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1984-12-21
- Routes
- ORAL
- Dosage Forms
- TABLET, SOLUTION, CAPSULE
Companies
HALSEY MIKART CARACO LANNETT CO INC ABHAI LLC PRINSTON INC VINTAGE PHARMS NESHER PHARMS WATSON LABS FLORIDA AMNEAL PHARMS NY WATSON LABS MALLINCKRODT USL PHARMA IVAX PHARMS GENUS WES PHARMA INC VINTAGE PHARMS LLC ABLE Teva AUROLIFE PHARMA LLC STRIDES PHARMA INTL PH HEALTH NOVEL LABS INC HIBROW HLTHCARE SANALUZ MUTUAL PHARM CHARTWELL RANBAXY LABS LTD ALVOGEN RANBAXY PHARM ASSOC EPIC PHARMA LLC UCB INC Sun Pharma RHODES PHARMS SPECGX LLC TRIS PHARMA INC ELITE LABS INC GRANULES MALLINCKRODT INC AMNEAL PHARMS ASCENT PHARMS INC APIL Novartis UPSHER SMITH LABS
Website: ↗
HYDROCODONE BITARTRATE AND ACETAMINOPHEN Approval History
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What HYDROCODONE BITARTRATE AND ACETAMINOPHEN Treats
89 FDA approvalsOriginally approved for its first indication in 1984 . Covers 89 distinct patient populations.
- Other (89)
Other
(89 approvals)- • Approved indication (Dec 1984)
- • Approved indication (Jul 1985)
- • Approved indication (Aug 1985)
- • Approved indication (Feb 1986)
- • Approved indication (Jul 1986)
- • Approved indication (Apr 1988)
- • Approved indication (Jun 1988)
- • Approved indication (Sep 1988)
- • Approved indication (Dec 1988)
- • Approved indication (Dec 1988)
- • Approved indication (Aug 1989)
- • Approved indication (Nov 1989)
- • Approved indication (Aug 1991)
- • Approved indication (Jan 1992)
- • Approved indication (Apr 1992)
- • Approved indication (May 1992)
- • Approved indication (Aug 1992)
- • Approved indication (Oct 1992)
- • Approved indication (Jun 1995)
- • Approved indication (Sep 1995)
- • Approved indication (Feb 1996)
- • Approved indication (Mar 1996)
- • Approved indication (Apr 1996)
- • Approved indication (Nov 1996)
- • Approved indication (Jan 1997)
- • Approved indication (Feb 1997)
- • Approved indication (Apr 1997)
- • Approved indication (Aug 1997)
- • Approved indication (Sep 1997)
- • Approved indication (Nov 1997)
- • Approved indication (Feb 1998)
- • Approved indication (Mar 1998)
- • Approved indication (Sep 1998)Label Letter
- • Approved indication (Apr 2000)Letter
- • Approved indication (May 2000)Letter
- • Approved indication (Jul 2000)Label Letter
- • Approved indication (Jun 2001)Label Letter
- • Approved indication (Jan 2002)
- • Approved indication (Oct 2002)
- • Approved indication (Oct 2002)
- • Approved indication (Nov 2002)
- • Approved indication (Nov 2002)
- • Approved indication (Jan 2003)
- • Approved indication (Jan 2003)
- • Approved indication (May 2003)
- • Approved indication (May 2003)
- • Approved indication (Aug 2003)
- • Approved indication (Sep 2003)
- • Approved indication (Oct 2003)
- • Approved indication (Jan 2006)
- • Approved indication (Aug 2006)
- • Approved indication (Aug 2006)
- • Approved indication (Feb 2007)
- • Approved indication (Aug 2007)
- • Approved indication (Apr 2008)
- • Approved indication (Dec 2008)
- • Approved indication (Feb 2010)
- • Approved indication (Jun 2010)
- • Approved indication (Jan 2011)
- • Approved indication (Jul 2011)
- • Approved indication (Jan 2012)
- • Approved indication (Apr 2012)
- • Approved indication (Mar 2013)
- • Approved indication (May 2013)
- • Approved indication (Apr 2016)
- • Approved indication (Jun 2016)
- • Approved indication (Jun 2016)
- • Approved indication (Jul 2016)Letter
- • Approved indication (Nov 2016)
- • Approved indication (Nov 2016)Letter
- • Approved indication (Dec 2016)
- • Approved indication (Mar 2017)
- • Approved indication (Mar 2017)
- • Approved indication (Jun 2017)
- • Approved indication (Jun 2017)
- • Approved indication (Jun 2017)Letter
- • Approved indication (Jun 2017)Letter
- • Approved indication (Oct 2017)
- • Approved indication (Mar 2018)
- • Approved indication (Sep 2018)
- • Approved indication (Oct 2018)
- • Approved indication (Oct 2018)
- • Approved indication (Nov 2018)
- • Approved indication (Nov 2018)
- • Approved indication (Nov 2018)
- • Approved indication (Mar 2019)
- • Approved indication (Jan 2020)
- • Approved indication (Feb 2020)
- • Approved indication (Dec 2021)
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Pro Active Pipeline
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Pro Key Completed Trials
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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.
HYDROCODONE BITARTRATE 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.