Data updated: Mar 10, 2026
ACETAMINOPHEN
ACETAMINOPHEN
Approved 1980-04-22
27
Indications
--
Phase 3 Trials
45
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1980-04-22
- Routes
- INTRAVENOUS, ORAL, RECTAL
- Dosage Forms
- POWDER, TABLET, EXTENDED RELEASE, SOLUTION, SUPPOSITORY
Companies
RISING GRANULES INFORLIFE PERRIGO NEW YORK ABLE TARO B BRAUN MEDICAL ZYDUS PHARMS HERITAGE WOCKHARDT BIO AG OHM LABS Sun Pharma EUGIA PHARMA Viatris GLAND ACINO PRODS ASPIRO CAPLIN Novartis Aurobindo Pharma MARKSANS PHARMA PERRIGO Hikma Baxter Fresenius Kabi
Active Ingredient: ACETAMINOPHEN
Website: ↗
ACETAMINOPHEN Approval History
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What ACETAMINOPHEN Treats
27 FDA approvalsOriginally approved for its first indication in 1980 . Covers 27 distinct patient populations.
- Other (27)
Other
(27 approvals)- • Approved indication (Apr 1980)
- • Approved indication (Dec 1986)
- • Approved indication (Apr 1987)
- • Approved indication (May 1987)
- • Approved indication (Feb 2000)Letter
- • Approved indication (Mar 2002)Letter
- • Approved indication (Nov 2009)
- • Approved indication (Dec 2011)
- • Approved indication (Oct 2015)Label Letter
- • Approved indication (Mar 2016)
- • Approved indication (Jun 2016)
- • Approved indication (Nov 2016)
- • Approved indication (May 2018)
- • Approved indication (Apr 2019)
- • Approved indication (Aug 2020)
- • Approved indication (Oct 2020)
- • Approved indication (Jan 2021)Label Letter
- • Approved indication (Feb 2021)Label Letter
- • Approved indication (Aug 2021)
- • Approved indication (Sep 2021)
- • Approved indication (Jun 2022)Label Letter
- • Approved indication (Jul 2022)
- • Approved indication (Oct 2022)
- • Approved indication (Apr 2023)
- • Approved indication (May 2023)
- • Approved indication (Apr 2025) New
- • Approved indication (Dec 2025) New
🔬
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 FDA Label Details
ProACETAMINOPHEN Patents & Exclusivity
Latest Patent: Apr 2030
Patents (1 active)
US8741959
Expires Apr 19, 2030
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.