Data updated: Mar 10, 2026
ACETAMINOPHEN AND CODEINE PHOSPHATE
ACETAMINOPHEN
Approved 1976-05-10
52
Indications
--
Phase 3 Trials
49
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1976-05-10
- Routes
- ORAL
- Dosage Forms
- TABLET, SOLUTION, CAPSULE
Companies
HALSEY MUTUAL PHARM PUREPAC PHARM LEDERLE DURAMED PHARMS BARR SUPERPHARM MIKART ROXANE PAI HOLDINGS WARNER CHILCOTT VALEANT PHARM INTL WATSON LABS SPECGX LLC ABLE Teva CHARTWELL AM THERAP HIBROW HLTHCARE FOSUN PHARMA WHITEWORTH TOWN PLSN USL PHARMA ANI PHARMS RHODES PHARMS AMNEAL PHARMS NY KV PHARM STRIDES PHARMA GENUS LIFESCIENCES STRIDES PHARMA INTL AUROLIFE PHARMA LLC EVERYLIFE Novartis PURACAP PHARM WATSON LABS FLORIDA VITARINE PHARMOBEDIENT CHARTWELL MOLECULAR Sun Pharma ELITE LABS INC DAVA PHARMS INC
Website: ↗
ACETAMINOPHEN AND CODEINE PHOSPHATE Approval History
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What ACETAMINOPHEN AND CODEINE PHOSPHATE Treats
52 FDA approvalsOriginally approved for its first indication in 1976 . Covers 52 distinct patient populations.
- Other (52)
Other
(52 approvals)- • Approved indication (May 1976)
- • Approved indication (Feb 1977)
- • Approved indication (Aug 1977)
- • Approved indication (Dec 1977)
- • Approved indication (Jan 1978)
- • Approved indication (Mar 1978)
- • Approved indication (Mar 1978)
- • Approved indication (Apr 1978)
- • Approved indication (Jun 1978)
- • Approved indication (Jul 1978)
- • Approved indication (Jul 1978)
- • Approved indication (Nov 1978)
- • Approved indication (Mar 1979)
- • Approved indication (May 1979)
- • Approved indication (Jan 1980)
- • Approved indication (Aug 1980)
- • Approved indication (Feb 1981)
- • Approved indication (Jul 1981)
- • Approved indication (Aug 1981)
- • Approved indication (Apr 1982)
- • Approved indication (May 1982)
- • Approved indication (Jun 1982)
- • Approved indication (Dec 1982)
- • Approved indication (Dec 1983)
- • Approved indication (Feb 1984)
- • Approved indication (Jun 1984)
- • Approved indication (Jun 1984)
- • Approved indication (Mar 1985)
- • Approved indication (Oct 1985)
- • Approved indication (Feb 1986)
- • Approved indication (Mar 1986)
- • Approved indication (May 1986)
- • Approved indication (Jul 1986)
- • Approved indication (Mar 1987)
- • Approved indication (Feb 1988)
- • Approved indication (Sep 1988)
- • Approved indication (Apr 1989)
- • Approved indication (Sep 1991)
- • Approved indication (Jul 1992)
- • Approved indication (Oct 1992)
- • Approved indication (Dec 1994)
- • Approved indication (Apr 1996)
- • Approved indication (Sep 1996)Label Letter
- • Approved indication (Nov 1997)
- • Approved indication (May 2001)Letter
- • Approved indication (Aug 2002)Letter
- • Approved indication (Jan 2003)
- • Approved indication (May 2008)
- • Approved indication (Nov 2011)
- • Approved indication (Apr 2013)
- • Approved indication (Jun 2019)
- • Approved indication (Sep 2019)
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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.
ACETAMINOPHEN AND CODEINE PHOSPHATE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.