Data updated: May 26, 2026
DARVOCET-N 50 (acetaminophen)
Pain
Approved 1972-12-19
1
Indication
--
Phase 3 Trials
53
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1972-12-19
- Routes
- ORAL
- Dosage Forms
- TABLET
DARVOCET-N 50 Approval History
1973
1974
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1989
1990
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1993
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2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
43 FDA actions from 1972 to 2009
Jan 2007 SUPPL
Mfg · Manufacturing (CMC)
May 2006 SUPPL
Mfg · Manufacturing (CMC)
Jul 2005 SUPPL
Mfg
Apr 2005 SUPPL
Mfg
Feb 2005 SUPPL
Mfg
Oct 2001 SUPPL
Label
Feb 1999 SUPPL
Mfg
Oct 1998 SUPPL
Mfg
Aug 1998 SUPPL
Mfg
Apr 1998 SUPPL
Mfg
May 1997 SUPPL
Mfg
Mar 1995 SUPPL
Label
Mar 1995 SUPPL
Mfg
Sep 1994 SUPPL
Label
Aug 1994 SUPPL
Label
Apr 1994 SUPPL
Mfg
Dec 1993 SUPPL
Mfg
Sep 1992 SUPPL
Mfg
Apr 1987 SUPPL
Mfg
Oct 1986 SUPPL
Label
Apr 1986 SUPPL
Label
Apr 1986 SUPPL
Label
Aug 1984 SUPPL
Mfg
Aug 1984 SUPPL
Label
Oct 1981 SUPPL
Label
May 1981 SUPPL
Label
Apr 1980 SUPPL
Label
Jan 1980 SUPPL
Mfg
Nov 1979 SUPPL
Mfg
Sep 1979 SUPPL
Label
Jul 1979 SUPPL
Label
Jun 1979 SUPPL
Mfg
Oct 1978 SUPPL
Mfg
Jun 1977 SUPPL
Label
May 1977 SUPPL
Mfg
Sep 1976 SUPPL
Mfg
Jun 1974 SUPPL
Mfg
Dec 1972 ORIGINAL
New Combo
What DARVOCET-N 50 Treats
1 FDA approvalsOriginally approved for its first indication in 1972 .
- Other (1)
Other
(1 approval)- • Approved indication (Dec 1972)
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Clinical Trial Registry
251 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04165096 results posted | 3475-01C MK-3475-01C, KEYMAKER-U01C | Ph 2 | completed | KEYMAKER-U01 Substudy 3: Efficacy and Safety Study of Pembrolizumab (MK-3475) When Used With Investigational Agents in Participants With Advanced Non-small Cell Lung Cancer (NSCLC), Previously Treated With Anti-programmed Cell Death Receptor Ligand 1 (PD-L1) Therapy (MK-3475-01C/KEYMAKER-U01C) |
| NCT06009926 | NCI-2023-06404 NCI-2023-06404, STUDY00003544 | Ph 2 | active not recruiting | Evaluation of Broccoli Seed and Sprout Extract for Detoxification of Carcinogens in Firefighters |
| NCT07570173 | 1045-005 MK-1045-005, 2025-522267-15-00 | Ph 2, Ph 3 | recruiting | A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005) |
| NCT05878015 | 23-000547 | Ph 4 | enrolling by invitation | A Study of Intravenous Acetaminophen for Small Bowel Obstruction |
| NCT07567924 | SIUT-ERC-2024/A-475 | Ph 4 | active not recruiting | Comparison Between Pregabalin and Acetaminophen for the Treatment of Post-Mastectomy Pain Syndrome |
| NCT04221477 REGENCY results posted | CA41705 2019-004034-42, 2023-503628-22-00 | Ph 3 | active not recruiting | A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis |
| NCT06043323 | 2023-0087 NCI-2023-07173 | Ph 2 | recruiting | A Phase II Study of Axicabtagene Ciloleucel, an Anti-CD19 Chimeric Antigen Receptor (CAR) Tcell Therapy, in Combination With Radiotherapy (RT) in Relapsed/Refractory Follicular Lymphoma |
| NCT07571252 | 2603555595 | Ph 4 | not yet recruiting | Impact of Preemptive Analgesia on Postoperative Pain in Orthognathic Surgery |
| NCT06762600 | HRS-4729-101 | Ph 1 | completed | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HRS-4729 Injection in Healthy Subjects |
| NCT07525791 | NN9662-8158 U1111-1328-3457 | Ph 1 | recruiting | A Research Study Looking Into How NNC0662-0419 Works With Birth Control Pills and Emptying of the Stomach in Women Not Able to Become Pregnant With Excess Body Weight |
| NCT07508241 | C6491010 MET097-25-106 | Ph 1 | recruiting | A Study to Learn About the Effect of Study Medicine Called PF-08653944 on How Quickly the Stomach Empties Its Content in Healthy Adults With Overweight or Obesity |
| NCT07525219 | IRB00146434 | Ph 3 | not yet recruiting | Suzetrigine Frame Trial Comparing Suzetrigine and Acetaminophen |
| NCT03823534 | 28927 | Ph 3 | recruiting | Post-Op Pain Control for Prophylactic Intramedullary Nailing. |
| NCT05722002 CARES | HUM00215416 CER-2021C1-22398 | Ph 4 | recruiting | Comparing Analgesic Regimen Effectiveness and Safety for Surgery (CARES) Trial |
| NCT05285813 | 2021-1124 NCI-2022-02215 | Ph 2 | active not recruiting | A Phase II Study of Vibecotamab (XmAb14045) for MRD- Positive AML and MDS After Hypomethylating Agent Failure |
| NCT03759028 | IRB# 18-001158 | Ph 4 | recruiting | Supracondylar Post-Operative Pain Study |
| NCT04629248 MAJESTY | WA41937 2020-003233-38, 2023-506525-11-00 | Ph 3 | active not recruiting | A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy |
| NCT06214468 | 23-067/2026659-2 | Ph 1 | completed | Protective Effect of Nicotinamide Riboside Against Acetaminophen Toxicity |
| NCT06187584 results posted | STUDY00000286 | Ph 4 | completed | Supracondylar Humerus Fracture (SCHF) Post-Op Study Between Opioid and Non-Opioid Pain Management |
| NCT07502001 | HDM1005-104 | Ph 1 | not yet recruiting | Influence of HDM1005 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin |
| NCT04268498 ADVANCE | 20201316 2019-001645-41, 19-339 | Ph 2 | active not recruiting | A Study of Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone in Patients With Newly-Diagnosed Multiple Myeloma |
| NCT03818932 results posted | 123192 | Ph 2, Ph 3 | completed | Nonopioid Analgesia After Anterior Cruciate Ligament Reconstruction |
| NCT03258593 results posted | 170157 17-C-0157 | Ph 1 | completed | Durvalumab and Vicineum in Subjects With High-Grade Non-Muscle-Invasive Bladder Cancer Previously Treated With Bacillus Calmette-Guerin (BCG) |
| NCT04459117 TREOCAPA | C19-29 2019-004297-26 | Ph 2, Ph 3 | completed | Prophylactic Treatment of the Ductus Arteriosus in Preterm Infants by Acetaminophen |
| NCT05896228 Iber-KDd | 20230227 | Ph 2 | recruiting | Iberdomide, Daratumumab, Carfilzomib, and Dexamethasone (Iber-KDd) in Patients With Relapsed/Refractory Multiple Myeloma |
| NCT02858310 results posted | 160154 16-C-0154 | Ph 1, Ph 2 | completed | E7 TCR T Cells for Human Papillomavirus-Associated Cancers |
| NCT05597878 | IRB00091354 WFBCCC 01122 | Ph 2, Ph 3 | suspended | Opioid-Free Pain Control Regimen Following Robotic Radical Prostatectomy |
| NCT06671002 CARES for Kids | HUM00252793 BPS-2023C1-32147 | Ph 4 | recruiting | Comparing Analgesic Regimen Effectiveness and Safety for Surgery for Kids Trial |
| NCT03974932 results posted | HTX-011-306 | Ph 3 | completed | Total Knee Arthroplasty (TKA) Study of HTX-011 in an Multimodal Analgesic Regimen (MMA) Regimen |
| NCT03695367 results posted | HTX-011-215 | Ph 2 | completed | Phase 2 Herniorrhaphy Study for Opioid Elimination |
| NCT07429032 | 20230012 | Ph 1 | completed | The Effect of AMG 133 on Gastric Emptying |
| NCT06356571 SubQSA | LPS18183 U1111-1298-7348 | Ph 2 | recruiting | A Study to Investigate Subcutaneous Isatuximab in Combination With Weekly Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma |
| NCT04224558 | Pro00051458 | Ph 1, Ph 2 | recruiting | Stem Cell Transplantation in Crohn's Disease |
| NCT06994442 OPTICOM | 24-12028276 U01HD116260 | Ph 3 | recruiting | Optimizing Pain Treatment in Children On Mechanical Ventilation |
| NCT03913559 | INOMRD NCI-2019-01062 | Ph 2 | terminated | Inotuzumab Ozogamicin for Children With MRD Positive CD22+ Lymphoblastic Leukemia |
| NCT05488847 results posted | 15592 | Ph 4 | active not recruiting | Opioid-Free Pain Protocol After Shoulder Arthroplasty |
| NCT07101445 | STUDY00008909 NCI-2025-03018, STUDY00008909 | Ph 4 | recruiting | Evaluating Premedication Regimens (Methylprednisolone vs Dexamethasone-based) for the Prevention of Systemic and Injection Site Reactions to Motixafortide in Patients With Multiple Myeloma Undergoing Stem Cell Mobilization, PARADE Trial |
| NCT05640674 results posted | 52475 | Ph 4 | terminated | Post-operative Pain Management in Children With Supracondylar Humerus Fractures |
| NCT04918147 results posted | DAIT AIG01 UM1AI144298, NIAID CRMS ID#: 38708 | Ph 2 | terminated | Elotuzumab in Immunoglobulin G4-Related Disease (IgG4-RD) |
| NCT01391962 results posted | 110200 11-C-0200 | Ph 2 | completed | Sunitinib or Cediranib for Alveolar Soft Part Sarcoma |
| NCT04681105 | 20472 NCI-2020-08118, 20472 | Ph 1 | completed | Flotetuzumab for the Treatment of Relapsed or Refractory Advanced CD123-Positive Hematological Malignancies |
| NCT06997016 | Baylor IRB #025-220 | Ph 4 | enrolling by invitation | Enhanced Recovery After Surgery (ERAS) in Live Donor Kidney Transplant Recipients |
| NCT02797522 results posted | ARC5211001 | Ph 1 | terminated | A Study of ARC-521 Injection in Normal Adult Volunteers and Patients With Chronic Hepatitis B (CHB) |
| NCT05211336 results posted | 10000516 000516-C | Ph 1 | active not recruiting | Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (VIPOR) for Diffuse Large B-cell Lymphoma Involving the Central Nervous System |
| NCT03978767 PANDA | 201901202 | Ph 2 | completed | Preeclampsia And Nonsteroidal Drugs for Analgesia: a Randomized Non Inferiority Trial |
| NCT05704049 IZALCO | ACT17453 U1111-1280-5090, 2023-508870-27 | Ph 2 | active not recruiting | A Study to Investigate Subcutaneous Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma |
| NCT05603832 | 100-CIP02-P | Ph 3 | completed | A Phase 3 Study of F14 for Management of Pain Following Total Knee Replacement |
| NCT04270409 | EFC15992 U1111-1222-7068, 2023-507419-37 | Ph 3 | active not recruiting | Isatuximab in Combination With Lenalidomide and Dexamethasone in High-risk Smoldering Multiple Myeloma |
| NCT03997851 results posted | 20190133 | Ph 1, Ph 2 | completed | Topical Acetaminophen for Itch Relief: a Proof of Concept Study in Healthy Subjects |
| NCT05035407 results posted | 10000045 000045-C | Ph 1 | terminated | T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers |
Showing 50 of 251 trials
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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.
DARVOCET-N 50 FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.