Application 212517
- Type
- ANDA
- Sponsor
- SCIEGEN PHARMS INC
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 |
|---|---|---|---|---|---|---|---|
| A212517-001 | NAPROXEN | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | |
| A212517-002 | NAPROXEN | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | |
| A212517-003 | NAPROXEN | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A212517-001 | AB |
| A212517-002 | AB |
| A212517-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A212517-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A212517-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A212517-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A212517-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A212517-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A212517-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A212517-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212517-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A212517-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212517-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212517-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A212517-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A212517-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212517-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A212517-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212517-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212517-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A212517-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212517-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212517-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A212517-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212517-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212517-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A212517-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212517-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212517-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A212517-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212517-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212517-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A212517-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212517-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212517-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A212517-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A212517-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A212517-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A212517-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212517-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212517-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A212517-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212517-001 | AB | 1 | 301d65b070ca… |
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 | Northwind Health Company, LLC | c986ba9a-6f48-8347-e053-2a95a90aa1c1 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 51655-743 |
| Naproxen | NAPROXEN | PHOENIX RX LLC | 43912294-77c9-eda8-e063-6394a90adf0a | 2025-11-14 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | A-S Medication Solutions | 8c3398bd-66b1-4a14-8aaa-e4a2d6749a08 | 2025-11-02 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | Medcore LLC | 129392c8-8ce1-4b78-8863-042db880095f | 2025-10-28 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | A-S Medication Solutions | cfa88511-40bb-4658-b606-44c68d0746b7 | 2025-10-08 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | A-S Medication Solutions | b500bdba-946a-41ff-855c-1f2937547d01 | 2025-10-08 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | Proficient Rx LP | e64b3b36-f96e-463e-aca8-8f6e86724bcf | 2025-07-01 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | A-S Medication Solutions | 7fef9311-471b-472c-b4f2-c952a2b3a255 | 2025-05-07 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 50090-5645 |
| Naproxen | NAPROXEN | Asclemed USA, Inc. | 1e406e47-408a-48cc-921e-52882a11581c | 2025-04-11 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 76420-264 |
| Naproxen | NAPROXEN | Direct_Rx | f499a207-02c8-a338-e053-2995a90accc0 | 2025-01-22 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | Advanced Rx Pharmacy of Tennessee, LLC | d292f376-1844-b01c-e053-2a95a90a0927 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 80425-0175 |
| Naproxen | NAPROXEN | Quality Care Products, LLC | 1acfb8cc-6faf-4b3e-9304-4819c42de0a6 | 2024-12-18 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 55700-888 |
| Naproxen | NAPROXEN | Advanced Rx Pharmacy of Tennessee, LLC | 1431b769-5535-78d6-e063-6394a90a8423 | 2024-03-21 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | Asclemed USA, Inc. | 5a48c0d4-37bf-4c26-a9a7-5c67ff2adb4b | 2024-03-19 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | Medsource Pharmaceuticals | 12648efc-3be8-a915-e063-6394a90a3620 | 2024-02-27 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | Bryant Ranch Prepack | 1cdcaba5-5550-40f6-94cc-b0a98cc17d3c | 2024-01-11 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 63629-8514 |
| Naproxen | NAPROXEN | Bryant Ranch Prepack | d564f52d-171c-4e7d-974c-3a0e192e6c12 | 2024-01-11 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 63629-8515 |
| Naproxen | NAPROXEN | Proficient Rx LP | d0670241-f1f9-4fdf-83d4-547e7b800811 | 2022-11-01 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 71205-597 |
| Naproxen | NAPROXEN | Aphena Pharma Solutions - Tennessee, LLC | 98efdeb8-ea38-456e-953f-ba589727f284 | 2021-11-10 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 71610-597 |
| Naproxen | NAPROXEN | Aphena Pharma Solutions - Tennessee, LLC | 9c963e77-6e05-47d0-a8d3-e581777377b9 | 2021-08-19 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 71610-592 71610-591 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-5645 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50228-434 | Naproxen | Naproxen | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-434 | Naproxen | Naproxen | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-434 | Naproxen | Naproxen | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-435 | Naproxen | Naproxen | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-435 | Naproxen | Naproxen | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-435 | Naproxen | Naproxen | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-436 | Naproxen | Naproxen | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-436 | Naproxen | Naproxen | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 50228-436 | Naproxen | Naproxen | ScieGen Pharmaceuticals, Inc. | ANDA | Current |
| 51655-743 | Naproxen | Naproxen | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 55700-888 | Naproxen | Naproxen | Quality Care Products, LLC | ANDA | Current |
| 55700-888 | Naproxen | Naproxen | Quality Care Products, LLC | ANDA | Current |
| 55700-888 | Naproxen | Naproxen | Quality Care Products, LLC | ANDA | Current |
| 55700-987 | Naproxen | Naproxen | Quality Care Products, LLC | ANDA | Current |
| 60760-564 | Naproxen | Naproxen | ST. MARY'S MEDICAL PARK PHARMACY | ANDA | Current |
| 60760-564 | Naproxen | Naproxen | ST. MARY'S MEDICAL PARK PHARMACY | ANDA | Current |
| 60760-644 | Naproxen | Naproxen | ST. MARY'S MEDICAL PARK PHARMACY | ANDA | Current |
| 63629-8511 | Naproxen | Naproxen | Bryant Ranch Prepack | ANDA | Current |
| 63629-8511 | Naproxen | Naproxen | Bryant Ranch Prepack | ANDA | Current |
| 63629-8511 | Naproxen | Naproxen | Bryant Ranch Prepack | ANDA | Current |
| 63629-8512 | Naproxen | Naproxen | Bryant Ranch Prepack | ANDA | Current |
| 63629-8512 | Naproxen | Naproxen | Bryant Ranch Prepack | ANDA | Current |
| 63629-8512 | Naproxen | Naproxen | Bryant Ranch Prepack | ANDA | Current |
| 63629-8513 | Naproxen | Naproxen | Bryant Ranch Prepack | ANDA | Current |
| 63629-8513 | Naproxen | Naproxen | Bryant Ranch Prepack | ANDA | Current |
| 63629-8513 | Naproxen | Naproxen | Bryant Ranch Prepack | ANDA | Current |
| 63629-8514 | Naproxen | Naproxen | Bryant Ranch Prepack | ANDA | Current |
| 63629-8514 | Naproxen | Naproxen | Bryant Ranch Prepack | ANDA | Current |
| 63629-8514 | Naproxen | Naproxen | Bryant Ranch Prepack | ANDA | Current |
| 63629-8515 | Naproxen | Naproxen | Bryant Ranch Prepack | ANDA | Current |
| 63629-8515 | Naproxen | Naproxen | Bryant Ranch Prepack | ANDA | Current |
| 63629-8515 | Naproxen | Naproxen | Bryant Ranch Prepack | ANDA | Current |
| 67296-1797 | Naproxen | Naproxen | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1797 | Naproxen | Naproxen | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1797 | Naproxen | Naproxen | RedPharm Drug, Inc. | ANDA | Current |
| 68071-2396 | Naproxen | Naproxen | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2396 | Naproxen | Naproxen | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2467 | Naproxen | Naproxen | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2769 | Naproxen | Naproxen | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2793 | Naproxen | Naproxen | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7946 | Naproxen | Naproxen | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-3486 | Naproxen | Naproxen | REMEDYREPACK INC. | ANDA | Current |
| 70518-3486 | Naproxen | Naproxen | REMEDYREPACK INC. | ANDA | Current |
| 70518-3514 | Naproxen | Naproxen | REMEDYREPACK INC. | ANDA | Current |
| 70518-3514 | Naproxen | Naproxen | REMEDYREPACK INC. | ANDA | Current |
| 70934-803 | Naproxen | Naproxen | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 70934-803 | Naproxen | Naproxen | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 71205-597 | Naproxen | Naproxen | Proficient Rx LP | ANDA | Current |
| 71205-597 | Naproxen | Naproxen | Proficient Rx LP | ANDA | Current |
| 71205-597 | Naproxen | Naproxen | Proficient Rx LP | ANDA | Current |
| 71205-597 | Naproxen | Naproxen | Proficient Rx LP | ANDA | Current |
| 71205-597 | Naproxen | Naproxen | Proficient Rx LP | ANDA | Current |
| 71205-597 | Naproxen | Naproxen | Proficient Rx LP | ANDA | Current |
| 71335-1850 | Naproxen | Naproxen | Bryant Ranch Prepack | ANDA | Current |
| 71335-1869 | Naproxen | Naproxen | Bryant Ranch Prepack | ANDA | Current |
| 71335-1869 | Naproxen | Naproxen | Bryant Ranch Prepack | ANDA | Current |
| 71335-1869 | Naproxen | Naproxen | Bryant Ranch Prepack | ANDA | Current |
| 71610-560 | Naproxen | Naproxen | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-591 | Naproxen | Naproxen | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-592 | Naproxen | Naproxen | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-597 | Naproxen | Naproxen | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-597 | Naproxen | Naproxen | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 76420-264 | Naproxen | Naproxen | Asclemed USA, Inc. | ANDA | Current |
| 77771-434 | Naproxen | Naproxen | Radha Pharmaceuticals, Inc. | ANDA | Current |
| 77771-435 | Naproxen | Naproxen | Radha Pharmaceuticals, Inc. | ANDA | Current |
| 77771-436 | Naproxen | Naproxen | Radha Pharmaceuticals, Inc. | ANDA | Current |
| 80175-0436 | Naproxen | Naproxen | Central Packaging | ANDA | Current |
| 80175-0436 | Naproxen | Naproxen | Central Packaging | ANDA | Current |
| 80175-0436 | Naproxen | Naproxen | Central Packaging | ANDA | Current |
| 80425-0175 | Naproxen | Naproxen | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |
| 80425-0175 | Naproxen | Naproxen | Advanced Rx Pharmacy of Tennessee, LLC | ANDA | Current |