Sold as Naprosyn, Ec-Naprosyn. Every FDA application for this active ingredient: 3 branded and 37 generic.
As of Nov 13, 2026, FDA lists 40 applications for Naproxen (sold as Naprosyn, Ec-Naprosyn), first approved Mar 11, 1976, with 3 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Naproxen | Part D | $25.2M | -25% | 1,334,761 |
| Naproxen Sodium | Part D | $2.2M | -22% | 35,038 |
| Naproxen Sodium ER | Part D | $2.1M | +12% | 1,092 |
| Naproxen Sodium Cr | Part D | $838K | -28% | 620 |
| Naprelan | Part D | $35K | -49% | 11 |
| Ec-Naproxen | Part D | $0K | -100% | 0 |
| Study | Phase | Status | Posted |
|---|---|---|---|
| Safety and Tolerability of Metformin and Naproxen for Cancer Prevention in Fanconi AnemiaFanconi Anemia, Head and Neck Cancer · Rockefeller University | Phase 1 | Recruiting | Oct 28, 2026 |
| Reducing Opioid Use After Upper Extremity Surgery: Testing Lower Prescriptions and Pill QuantityOpioid Abuse (Disorder), Opioid Analgesia · AdventHealth | Phase 4 | Enrolling by invitation | Aug 6, 2026 |
| NSAIDS Following Elective Lumbar Spine FusionNSAID (Non-Steroidal Anti-Inflammatory Drug), Lumbar Spine Fusion · Rothman Institute Orthopaedics | Phase 3 | Enrolling by invitation | Aug 4, 2026 |
| Clinical and Economic Evaluation of Point-of-care Ultrasound-guided Infiltration for Subacromial and Carpal Tunnel Syndromes in Primary Care: a Cluster-randomized Study Protocol.Subacromial Impingement Syndrome, Carpal Tunnel Syndrome (CTS) · Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina | Phase 4 | Active, not recruiting | Jul 9, 2026 |
| Naproxen Versus Placebo as Adjunct Treatment of CellulitisCellulitis, Skin Disease, Infectious · Ottawa Hospital Research Institute | Phase 3 | Not yet recruiting | Jun 24, 2026 |
| Effectiveness of Opioid vs Pregabalin Plus Naproxen Sodium in Pain Management of Oral Cancer PatientsOral Cancer, Oral Cavity Cancer · Mayo Hospital Lahore | Not applicable | Enrolling by invitation | May 26, 2026 |
| Human Experimental Models of Pain (HEMP)Acute Pain · National Center for Complementary and Integrative Health (NCCIH) | Not applicable | Not yet recruiting | Apr 24, 2026 |
| The Effectiveness of Topical Prilocaine-Lidocaine Cream Plus Acetaminophen and Naproxen Compared to Lidocaine Injection Plus Acetaminophen and Naproxen to Manage Pain During IntraUterine Device InsertionPain During Intrauterine Device Insertion · Monakshi Sawhney | Phase 4 | Not yet recruiting | Apr 22, 2026 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Mar 11, 1976 | NaprosynNDA 17581 · New molecular entity | Atnahs Pharma US | 78 | Marketed |
| Mar 23, 1987 | NaprosynNDA 18965 · New dosage form | Atnahs Pharma US | 22 | Marketed |
| Oct 30, 1992 | NaproxenANDA 74110 | Hamilton Pharms | 2 | Discontinued |
| Dec 21, 1993 | NaproxenANDA 74105 | Dava Pharms Inc | 5 | Discontinued |
| Dec 21, 1993 | NaproxenANDA 74121 | Pharmobedient | 15 | Discontinued |
| Dec 21, 1993 | NaproxenANDA 74129 | Teva | 11 | Discontinued |
| Dec 21, 1993 | NaproxenANDA 74140 | Granules | 28 | Marketed |
| Dec 21, 1993 | NaproxenANDA 74201 | Teva | 19 | Marketed |
| Dec 21, 1993 | NaproxenANDA 74207 | Teva Pharms | 12 | Discontinued |
| Feb 28, 1994 | NaproxenANDA 74211 | Roxane | 5 | Discontinued |
| Mar 30, 1994 | NaproxenANDA 74190 | Hikma | 15 | Marketed |
| Oct 14, 1994 | Ec-NaprosynNDA 20067 · New dosage form | Atnahs Pharma US | 20 | Marketed |
| Feb 10, 1995 | NaproxenANDA 74163 | Watson Labs Teva | 8 | Discontinued |
| Feb 28, 1995 | NaproxenANDA 74111 | Ivax Sub Teva Pharms | 3 | Discontinued |
| Apr 28, 1995 | NaproxenANDA 74410 | Chartwell Molecules | 11 | Discontinued |
| May 31, 1995 | NaproxenANDA 74457 | Watson Labs | 6 | Discontinued |
| Apr 11, 1996 | NaproxenANDA 74216 | Teva | 0 | Discontinued |
| Jun 27, 1996 | NaproxenANDA 74182 | Pliva | 1 | Discontinued |
| Feb 18, 1998 | NaproxenANDA 75061 | Fosun Pharma | 11 | Discontinued |
| Feb 24, 1998 | NaproxenANDA 74936 | Actavis Elizabeth | 2 | Discontinued |
| Jun 30, 1998 | NaproxenANDA 75227 | Teva | 9 | Marketed |
| May 26, 1999 | NaproxenANDA 75337 | Pliva | 6 | Discontinued |
| Apr 19, 2001 | NaproxenANDA 75390 | Aurobindo Pharma USA | 5 | Marketed |
| Dec 18, 2001 | NaproxenANDA 75927 | Amneal Pharms Ny | 11 | Marketed |
| Jan 14, 2004 | NaproxenANDA 76494 | Hikma | 7 | Discontinued |
| Apr 27, 2005 | NaproxenANDA 77339 | L Perrigo Co | 3 | Discontinued |
| Mar 28, 2007 | NaproxenANDA 78250 | Glenmark Pharms Ltd | 6 | Marketed |
| Jun 7, 2007 | NaproxenANDA 78620 | Zydus Pharms USA | 5 | Marketed |
| Feb 14, 2011 | NaproxenANDA 91416 | Pharmazone | 1 | Marketed |
| Aug 24, 2011 | NaproxenANDA 91305 | Invagen Pharms | 4 | Discontinued |
| Sep 19, 2011 | NaproxenANDA 91432 | Nuvo Pharms Inc | 5 | Marketed |
| Nov 8, 2011 | NaproxenANDA 200429 | Aurobindo Pharma | 7 | Marketed |
| Feb 21, 2020 | NaproxenANDA 212517 | Sciegen Pharms | 2 | Marketed |
| Jul 31, 2020 | NaproxenANDA 212705 | Amneal | 0 | Marketed |
| Mar 10, 2021 | NaproxenANDA 211910 | Novitium Pharma | 0 | Marketed |
| Jun 7, 2022 | NaproxenANDA 215776 | Hetero Labs Ltd Iii | 2 | Marketed |
| May 31, 2023 | NaproxenANDA 216908 | Tp Anda Holdings | 1 | Marketed |
| Jun 12, 2024 | NaproxenANDA 218497 | Novitium Pharma | 2 | Marketed |
| Oct 3, 2025 | NaproxenANDA 216504 | Aurobindo Pharma | 0 | Discontinued |
| — | NaproxenANDA 74263 | Purepac Pharm | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Teva
Aurobindo Pharma