Application 078250
- Type
- ANDA
- Sponsor
- GLENMARK GENERICS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NAPROXEN | NAPROXEN | TABLET;ORAL | 250MG | No | No |
| 002 | NAPROXEN | NAPROXEN | TABLET;ORAL | 375MG | No | No |
| 003 | NAPROXEN | NAPROXEN | TABLET;ORAL | 500MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078250-001 | NAPROXEN | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-03-28 | |
| A078250-002 | NAPROXEN | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-03-28 | |
| A078250-003 | NAPROXEN | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-03-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078250-001 | AB |
| A078250-002 | AB |
| A078250-003 | AB |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078250-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-03-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078250-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-03-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078250-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-03-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078250-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-03-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078250-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-03-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078250-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-03-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078250-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-03-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078250-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-03-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078250-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-03-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078250-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-03-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078250-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-03-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078250-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-03-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078250-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-03-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078250-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-03-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078250-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-03-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078250-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-03-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078250-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-03-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078250-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-03-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078250-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-03-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078250-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-03-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078250-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-03-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078250-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-03-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078250-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-03-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078250-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-03-28 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078250-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-03-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078250-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-03-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078250-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-03-28 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078250-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-03-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078250-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-03-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078250-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-03-28 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078250-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-03-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078250-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-03-28 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078250-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-03-28 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078250-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-03-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078250-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-03-28 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078250-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-03-28 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078250-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-03-28 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078250-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2007-03-28 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078250-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2007-03-28 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078250-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2007-03-28 | 8072bd15b7f6… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078250-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078250-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078250-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078250-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078250-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078250-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078250-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078250-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078250-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078250-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078250-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078250-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078250-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078250-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078250-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078250-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078250-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078250-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078250-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078250-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078250-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078250-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078250-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078250-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078250-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078250-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078250-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078250-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078250-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078250-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078250-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078250-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078250-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078250-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078250-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078250-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078250-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078250-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078250-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078250-001 | AB | 1 | 8072bd15b7f6… |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Naproxen | NAPROXEN | Unit Dose Solutions, Inc. | 55652203-e5f3-78dc-e063-6294a90a3e46 | 2026-06-29 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 |
| Naproxen | NAPROXEN | Coupler LLC | 545fe39a-4777-b149-e063-6394a90a53cf | 2026-06-16 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 |
| Naproxen | NAPROXEN | Coupler LLC | 53e6519a-cb52-85e2-e063-6394a90abdcf | 2026-06-10 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 |
| Naproxen | NAPROXEN | Coupler LLC | 52b8e52e-73be-3423-e063-6294a90af6e0 | 2026-05-26 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 |
| Naproxen | NAPROXEN | Bryant Ranch Prepack | 0041b483-34db-49a6-8665-f87e286cd0b8 | 2026-05-19 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 |
| Naproxen | NAPROXEN | A-S Medication Solutions | 4e97e645-552d-424b-990a-f94349a86f17 | 2026-01-30 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 |
| Naproxen | NAPROXEN | A-S Medication Solutions | 000155a8-709c-44e5-a75f-cd890f3a7caf | 2026-01-29 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 50090-0481 |
| Naproxen | NAPROXEN | A-S Medication Solutions | d06db628-f6f0-48e2-b538-69c0837c49e3 | 2026-01-29 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 50090-0482 50090-1583 |
| Naproxen | NAPROXEN | A-S Medication Solutions | 9d28422f-6f25-4f14-9272-e0907c971f33 | 2026-01-29 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 50090-0483 50090-1585 |
| Naproxen | NAPROXEN | Preferred Pharmaceuticals Inc. | 87acd650-ea8a-4396-be72-5568c4b1755c | 2026-01-23 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 |
| Naproxen Sodium | NAPROXEN SODIUM | Glenmark Pharmaceuticals Inc., USA | 6c5bb008-e66f-4ef0-bf84-aca7eb5983e9 | 2025-12-23 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 |
| Naproxen | NAPROXEN | American Health Packaging | 86a3e612-3bfe-432f-9afd-972bb8a6644e | 2025-09-25 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 60687-491 |
| Naproxen | NAPROXEN | A-S Medication Solutions | e63a034d-23ef-458f-88ed-8b6d73699621 | 2025-04-17 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 50090-2788 |
| Naproxen | NAPROXEN | Preferred Pharmaceuticals Inc. | 727913f6-9542-4a2d-9318-4b7ff521bffd | 2025-03-20 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 |
| Naproxen | NAPROXEN | Advanced Rx of Tennessee, LLC | af9aa7a0-e287-5935-e053-2995a90a1d11 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 |
| Naproxen | NAPROXEN | A-S Medication Solutions | bce23087-f055-4234-b75d-69dd43233190 | 2024-10-16 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 50090-1584 |
| Naproxen | NAPROXEN | Bryant Ranch Prepack | da61463f-f87b-4aba-b538-7264252cadb8 | 2024-09-05 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 |
| Naproxen | NAPROXEN | Bryant Ranch Prepack | 1fe9a6fc-940e-4a18-b3e9-b204fd67f263 | 2024-09-03 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 |
| Naproxen | NAPROXEN | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 205b1159-06e5-0d48-e063-6294a90acbd8 | 2024-08-23 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 |
| Naproxen | NAPROXEN | NuCare Pharmaceuticals, Inc. | 46dd3908-6feb-4f50-e054-00144ff88e88 | 2024-08-14 | Boxed warning, Warnings, Adverse reactions | 078250 ANDA078250 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0179-1978 | Naproxen | Naproxen | KAISER FOUNDATION HOSPITALS | ANDA | Current |
| 10544-277 | Naproxen | Naproxen | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-278 | Naproxen | Naproxen | Blenheim Pharmacal, Inc. | ANDA | Current |
| 12634-684 | Naproxen | Naproxen | Apotheca Inc. | ANDA | Current |
| 42254-158 | Naproxen | Naproxen | Rebel Distributors Corp | ANDA | Current |
| 42254-221 | Naproxen | Naproxen | Rebel Distributors Corp | ANDA | Current |
| 45865-610 | Naproxen | Naproxen | Medsource Pharmaceuticals | ANDA | Current |
| 45865-610 | Naproxen | Naproxen | Medsource Pharmaceuticals | ANDA | Current |
| 49999-049 | Naproxen | Naproxen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 49999-049 | Naproxen | Naproxen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 49999-049 | Naproxen | Naproxen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 49999-049 | Naproxen | Naproxen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 50090-0481 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-0481 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-0482 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-0482 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-0483 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-0483 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-0483 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-0483 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-1583 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-1583 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-1583 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-1583 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-1583 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-1583 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-1584 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-1584 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-1584 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-1585 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-1585 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-1585 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-2788 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50436-0188 | Naproxen | Naproxen | Unit Dose Services | ANDA | Current |
| 50436-0190 | Naproxen | Naproxen | Unit Dose Services | ANDA | Current |
| 50436-6608 | Naproxen | Naproxen | Unit Dose Services | ANDA | Current |
| 51655-626 | Naproxen | Naproxen | Northwind Pharmaceuticals | ANDA | Current |
| 51655-685 | Naproxen Sodium | Naproxen Sodium | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 52959-191 | Naproxen | Naproxen | H.J. Harkins Company, Inc. | ANDA | Current |
| 52959-271 | Naproxen Sodium | Naproxen | H.J. Harkins Company, Inc. | ANDA | Current |
| 53002-3111 | Naproxen | Naproxen | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-3111 | Naproxen | Naproxen | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-3241 | Naproxen | Naproxen | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53217-262 | Naproxen | Naproxen | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 53808-0386 | Naproxen | Naproxen | State of Florida DOH Central Pharmacy | ANDA | Current |
| 58118-0199 | Naproxen | Naproxen | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 58118-0199 | Naproxen | Naproxen | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 58118-0199 | Naproxen | Naproxen | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 58118-0199 | Naproxen | Naproxen | Clinical Solutions Wholesale, LLC | ANDA | Current |
| 60687-491 | Naproxen | Naproxen | American Health Packaging | ANDA | Current |
| 60687-491 | Naproxen | Naproxen | American Health Packaging | ANDA | Current |
| 60687-491 | Naproxen | Naproxen | American Health Packaging | ANDA | Current |
| 60760-140 | Naproxen | Naproxen | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-140 | Naproxen | Naproxen | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-190 | Naproxen | Naproxen | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-190 | Naproxen | Naproxen | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-190 | Naproxen | Naproxen | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 61919-162 | NAPROXEN | NAPROXEN | DIRECT RX | ANDA | Current |
| 61919-162 | NAPROXEN | NAPROXEN | DIRECT RX | ANDA | Current |
| 61919-162 | NAPROXEN | NAPROXEN | DIRECT RX | ANDA | Current |
| 61919-173 | NAPROXEN | NAPROXEN SODIUM | DIRECT RX | ANDA | Current |
| 61919-173 | NAPROXEN | NAPROXEN SODIUM | DIRECT RX | ANDA | Current |
| 61919-376 | NAPROXEN | NAPROXEN | Direct_Rx | ANDA | Current |
| 61919-376 | NAPROXEN | NAPROXEN | Direct_Rx | ANDA | Current |
| 61919-376 | NAPROXEN | NAPROXEN | Direct_Rx | ANDA | Current |
| 61919-376 | NAPROXEN | NAPROXEN | Direct_Rx | ANDA | Current |
| 61919-376 | NAPROXEN | NAPROXEN | Direct_Rx | ANDA | Current |
| 61919-376 | NAPROXEN | NAPROXEN | Direct_Rx | ANDA | Current |
| 63187-028 | Naproxen | Naproxen | Proficient Rx LP | ANDA | Current |
| 63187-028 | Naproxen | Naproxen | Proficient Rx LP | ANDA | Current |
| 63187-028 | Naproxen | Naproxen | Proficient Rx LP | ANDA | Current |
| 63187-028 | Naproxen | Naproxen | Proficient Rx LP | ANDA | Current |
| 63187-461 | Naproxen | Naproxen | Proficient Rx LP | ANDA | Current |
| 63187-461 | Naproxen | Naproxen | Proficient Rx LP | ANDA | Current |
| 63187-461 | Naproxen | Naproxen | Proficient Rx LP | ANDA | Current |
| 63187-535 | Naproxen | Naproxen | Proficient Rx LP | ANDA | Current |
| 63187-535 | Naproxen | Naproxen | Proficient Rx LP | ANDA | Current |
| 63629-6657 | Naproxen | Naproxen | Bryant Ranch Prepack | ANDA | Current |
| 63874-301 | Naproxen | Naproxen | Altura Pharmaceuticals, Inc. | ANDA | Current |
| 63874-325 | Naproxen | Naproxen | Altura Pharmaceuticals, Inc. | ANDA | Current |