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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212517-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2020-02-21 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212517-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2020-02-21 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A212517-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2020-02-21 | 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 | 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… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212517-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A212517-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212517-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212517-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A212517-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A212517-001 | 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 | PD-Rx Pharmaceuticals, Inc. | 24d44eb6-921e-4150-a6b2-81f42ced32ab | 2026-08-03 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | Preferred Pharmaceuticals Inc. | 49a00870-f580-4eb9-a95d-48fa956f147f | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | Preferred Pharmaceuticals, Inc. | 9f026fd5-f996-4383-b528-841d38d3dab5 | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 68788-7946 |
| Naproxen | NAPROXEN | HAWAII REPACK, INC. | 888efc91-b4de-4691-b84c-fb871e7a6dfe | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | St. Mary's Medical Park Pharmacy | e3a3e5d2-2d1e-74d3-e053-2995a90a82bf | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 60760-564 |
| Naproxen | NAPROXEN | REMEDYREPACK INC. | ccd95dfc-9236-4707-a715-6a12c91519ff | 2026-06-08 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | ST. MARY'S MEDICAL PARK PHARMACY | e3a4ab4a-b109-eb5e-e053-2a95a90afddd | 2026-06-07 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 60760-644 |
| Naproxen | NAPROXEN | Bryant Ranch Prepack | 2e72de28-e62b-44e0-b17d-500d13e0bcc6 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 71335-1869 |
| Naproxen | NAPROXEN | Bryant Ranch Prepack | bbc61c0a-491a-4f50-a7bf-2ca94c771568 | 2026-05-15 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 71335-1850 |
| Naproxen | NAPROXEN | Sportpharm LLC | 1c5b2bc1-26bb-4f88-bded-399263c82331 | 2026-04-24 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | Bryant Ranch Prepack | f18181f4-6b14-48a8-a149-e45b3360a250 | 2026-04-14 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 63629-8511 |
| Naproxen | NAPROXEN | Bryant Ranch Prepack | 97d6c4ef-13b1-4b0b-a15a-f0590019940d | 2026-04-14 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 63629-8513 |
| Naproxen | NAPROXEN | Bryant Ranch Prepack | 852fed15-e78b-47a8-aeb4-623dfe1edad9 | 2026-04-14 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 63629-8512 |
| Naproxen | NAPROXEN | REMEDYREPACK INC. | 6bb65680-76ea-46e5-ae70-f3091e360368 | 2026-04-10 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 70518-3486 |
| Naproxen | NAPROXEN | Radha Pharmaceuticals, Inc. | 1a2b9a82-5b79-45ee-94ed-7a6f8c8b5170 | 2026-03-30 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 77771-436 77771-435 77771-434 |
| Naproxen | NAPROXEN | ScieGen Pharmaceuticals, Inc. | 81e22c1f-f94d-46e9-8b7d-72dc2518319e | 2026-03-18 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 50228-435 50228-434 50228-436 |
| Naproxen | NAPROXEN | NuCare Pharmaceuticals,Inc. | c136cf75-4ad4-8634-e053-2a95a90a53a4 | 2026-03-13 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 68071-2396 |
| Naproxen | NAPROXEN | PD-Rx Pharmaceuticals, Inc. | fa2fe6fd-c476-dd29-e053-6294a90a9e9e | 2026-01-05 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | Northwind Health Company, LLC | db478961-d984-7c8e-e053-2995a90a8a12 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 |
| Naproxen | NAPROXEN | Northwind Health Company, LLC | c986ba9a-6f48-8347-e053-2a95a90aa1c1 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 212517 ANDA212517 51655-743 |
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 |