ANAPROX DS (naproxen sodium)
ANAPROX DS is indicated for the treatment of Arthritis; Back Pain; Menstrual Cramps; Headache; Toothache; Common Cold; Fever.
Details
- Status
- Prescription
- First Approved
- 1980-09-04
- Routes
- ORAL
- Dosage Forms
- TABLET
ANAPROX DS Approval History
What ANAPROX DS Treats
7 indicationsANAPROX DS is approved for 7 conditions since its original approval in 1980. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Arthritis
- Back Pain
- Menstrual Cramps
- Headache
- Toothache
- Common Cold
- Fever
ANAPROX DS Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ANAPROX DS's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ANAPROX DS treats. First-in-class if their pivotal trials read out positive.
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3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
9 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04145518 MCUP | EH19-040 R01HD098193-01A1 | Ph 4 | completed | Mechanistic Characterization of Uterine Pain |
| NCT04015596 results posted | 2019P000623 | Ph 4 | terminated | Trial of Naproxen Sodium for the Treatment of OCD in Children With PANDAS |
| NCT05761574 | CCSPAA005199 CCSPAA005199 | Ph 3 | completed | A Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen and Naproxen Sodium in Postoperative Dental Pain |
| NCT05982392 | 2889 | Ph 2, Ph 3 | completed | Effect of Preoperative Tramadol and Naproxen Sodium on Post Operative Pain |
| NCT01107236 | ICP-109-201 | Ph 2 | completed | Study to Evaluate Efficacy and Safety of IW-6118 in Patients Undergoing Third Molar Extraction |
| NCT03291418 | ATB-346-P2GIS | Ph 1, Ph 2 | completed | To Compare the Gastrointestinal Safety of a 14-Day Oral Dosing Regimen of ATB-346 to Sodium Naproxen in Healthy Subjects |
| NCT01090050 results posted | 112839 | Ph 4 | completed | Treximet in the Treatment of Chronic Migraine |
| NCT01300546 results posted | 114933 | Ph 4 | completed | Treximet Trademark (TM) in the Prevention and Modification of Disease Progression in Migraine |
| NCT00692016 Keifer | 13080 | Ph 1 | completed | Fast & Fed Pharmacokinetic (PK) Study |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
ANAPROX DS FDA Label Details
Indications & Usage
FDA Label (PDF)ANAPROX DS is indicated for the treatment of Arthritis; Back Pain; Menstrual Cramps; Headache; Toothache; Common Cold; Fever.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.