Application 075927
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS NY
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 |
|---|---|---|---|---|---|---|---|
| A075927-001 | NAPROXEN | NAPROXEN | 250MG | TABLET / ORAL | AB | 2001-12-18 | |
| A075927-002 | NAPROXEN | NAPROXEN | 375MG | TABLET / ORAL | AB | 2001-12-18 | |
| A075927-003 | NAPROXEN | NAPROXEN | 500MG | TABLET / ORAL | AB | 2001-12-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075927-001 | AB |
| A075927-002 | AB |
| A075927-003 | 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 | A075927-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2001-12-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075927-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2001-12-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075927-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2001-12-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075927-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2001-12-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075927-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2001-12-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075927-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2001-12-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075927-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2001-12-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075927-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2001-12-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075927-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2001-12-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075927-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2001-12-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075927-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2001-12-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075927-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2001-12-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075927-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2001-12-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075927-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2001-12-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075927-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2001-12-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075927-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2001-12-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075927-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2001-12-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075927-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2001-12-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075927-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2001-12-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075927-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2001-12-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075927-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2001-12-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075927-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2001-12-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075927-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2001-12-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075927-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2001-12-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075927-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2001-12-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075927-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2001-12-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075927-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2001-12-18 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075927-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2001-12-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075927-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2001-12-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075927-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2001-12-18 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075927-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2001-12-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075927-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2001-12-18 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075927-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2001-12-18 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075927-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2001-12-18 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075927-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2001-12-18 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075927-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2001-12-18 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075927-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2001-12-18 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075927-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2001-12-18 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075927-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2001-12-18 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A075927-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2001-12-18 | 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 | A075927-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075927-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075927-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075927-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075927-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075927-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075927-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075927-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075927-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075927-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075927-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075927-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075927-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075927-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075927-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075927-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075927-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075927-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075927-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075927-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075927-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075927-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075927-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075927-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075927-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075927-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075927-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075927-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075927-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075927-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075927-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075927-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075927-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075927-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075927-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075927-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075927-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075927-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075927-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A075927-001 | 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 | Preferred Pharmaceuticals Inc. | c5e52ddd-a909-487a-bb46-01ad35690665 | 2026-07-28 | Boxed warning, Warnings, Adverse reactions | 075927 ANDA075927 |
| Naproxen | NAPROXEN | A-S Medication Solutions | c5c8b6fd-f3f5-4fed-823c-9a80386b27b1 | 2026-06-03 | Boxed warning, Warnings, Adverse reactions | 075927 ANDA075927 50090-4638 |
| Naproxen | NAPROXEN | AvPAK | e6fbf8f1-b064-658d-17bb-e7d6320aa45f | 2026-03-24 | Boxed warning, Warnings, Adverse reactions | 075927 ANDA075927 50268-595 50268-594 |
| Naproxen | NAPROXEN | Northwind Health Company, LLC | ab6ec2c9-5df9-346c-e053-2a95a90ac81d | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | 075927 ANDA075927 |
| Naproxen | NAPROXEN | QPharma, Inc. | 307aa67f-53b9-4c60-a328-091bbf6338d4 | 2025-12-29 | Boxed warning, Warnings, Adverse reactions | 075927 ANDA075927 42708-043 |
| Naproxen | NAPROXEN | PD-Rx Pharmaceuticals, Inc. | 29d98cf3-a0f2-3f89-e054-00144ff88e88 | 2025-07-15 | Boxed warning, Warnings, Adverse reactions | 075927 ANDA075927 43063-650 |
| Naproxen | NAPROXEN | PD-Rx Pharmaceuticals, Inc. | 6573681e-e9be-440f-a818-a533b744648e | 2025-07-15 | Boxed warning, Warnings, Adverse reactions | 075927 ANDA075927 43063-600 |
| Naproxen | NAPROXEN | Amneal Pharmaceuticals LLC | c43a43e2-e867-448d-8f59-3efc7c077cbc | 2025-05-28 | Boxed warning, Warnings, Adverse reactions | 075927 ANDA075927 |
| Naproxen | NAPROXEN | Bryant Ranch Prepack | 9d7bc470-fbba-40a6-a56c-f681a3cee9cf | 2025-03-24 | Boxed warning, Warnings, Adverse reactions | 075927 ANDA075927 |
| Naproxen | NAPROXEN | Amneal Pharmaceuticals of New York LLC | 2718e0b7-1ce6-457e-bee9-11b634dfd353 | 2025-03-14 | Boxed warning, Warnings, Adverse reactions | 075927 ANDA075927 |
| Naproxen | NAPROXEN | Advanced Rx of Tennessee, LLC | af9ad850-57b5-a21d-e053-2a95a90ae68e | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 075927 ANDA075927 |
| Naproxen | NAPROXEN | Advanced Rx of Tennessee, LLC | af9a94a8-3825-eabd-e053-2a95a90acd58 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 075927 ANDA075927 |
| Naproxen | NAPROXEN | Bryant Ranch Prepack | a4f31070-4ee1-4d64-8b1d-40b9011e124b | 2024-08-20 | Boxed warning, Warnings, Adverse reactions | 075927 ANDA075927 |
| Naproxen | NAPROXEN | A-S Medication Solutions | 80233fa5-f8b4-42d5-a8c9-4a1d8fd4aba4 | 2023-10-01 | Boxed warning, Warnings, Adverse reactions | 075927 ANDA075927 50090-4637 |
| Naproxen | NAPROXEN | A-S Medication Solutions | 21930f73-d3c2-4462-a487-74ed871b74b2 | 2023-02-06 | Boxed warning, Warnings, Adverse reactions | 075927 ANDA075927 50090-4752 |
| Naproxen | NAPROXEN | A-S Medication Solutions | a5ea3a84-7acd-4f24-9f0f-9f871ce1b5f4 | 2023-02-06 | Boxed warning, Warnings, Adverse reactions | 075927 ANDA075927 50090-4636 |
| Naproxen | NAPROXEN | Proficient Rx LP | fc3ee94a-adb7-411e-a662-2f2c6ddbabaf | 2021-01-01 | Boxed warning, Warnings, Adverse reactions | 075927 ANDA075927 |
| Naproxen | NAPROXEN | NCS HealthCare of KY, Inc dba Vangard Labs | 62a12771-bde9-4bc3-9ce9-672c8e31f020 | 2017-10-12 | Boxed warning, Warnings, Adverse reactions | 075927 ANDA075927 0615-8094 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0440-1852 | Naproxen | Naproxen | Liberty Pharmaceuticals, Inc. | ANDA | Current |
| 0440-7852 | Naproxen | Naproxen | Liberty Pharmaceuticals, Inc. | ANDA | Current |
| 0615-7892 | Naproxen | Naproxen | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-8094 | Naproxen | Naproxen | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 10544-016 | Naproxen | Naproxen | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-019 | Naproxen | Naproxen | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-044 | Naproxen | Naproxen | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-922 | Naproxen | Naproxen | Blenheim Pharmacal,Inc. | ANDA | Current |
| 12634-498 | Naproxen | Naproxen | Apotheca Inc. | ANDA | Current |
| 21695-084 | Naproxen | Naproxen | Rebel Distributors Corp. | ANDA | Current |
| 21695-085 | Naproxen | Naproxen | Rebel Distributors Corp. | ANDA | Current |
| 21695-086 | Naproxen | Naproxen | Rebel Distributors Corp. | ANDA | Current |
| 33261-080 | Naproxen | Naproxen | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-081 | Naproxen | Naproxen | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-128 | Naproxen | Naproxen | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 35356-682 | Naproxen | Naproxen | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | ANDA | Current |
| 42291-628 | Naproxen | Naproxen | AvKARE, Inc. | ANDA | Current |
| 42291-628 | Naproxen | Naproxen | AvKARE, Inc. | ANDA | Current |
| 42291-628 | Naproxen | Naproxen | AvKARE | ANDA | Current |
| 42708-043 | Naproxen | Naproxen | QPharma Inc | ANDA | Current |
| 42708-043 | Naproxen | Naproxen | QPharma Inc | ANDA | Current |
| 42708-043 | Naproxen | Naproxen | QPharma Inc | ANDA | Current |
| 42708-043 | Naproxen | Naproxen | QPharma Inc | ANDA | Current |
| 42708-061 | Naproxen | Naproxen | QPharma Inc | ANDA | Current |
| 42708-061 | Naproxen | Naproxen | QPharma Inc | ANDA | Current |
| 42708-099 | Naproxen | Naproxen | QPharma Inc | ANDA | Current |
| 43063-344 | Naproxen | Naproxen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-344 | Naproxen | Naproxen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-344 | Naproxen | Naproxen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-344 | Naproxen | Naproxen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-600 | Naproxen | Naproxen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-600 | Naproxen | Naproxen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-600 | Naproxen | Naproxen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-600 | Naproxen | Naproxen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-600 | Naproxen | Naproxen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-600 | Naproxen | Naproxen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-600 | Naproxen | Naproxen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-650 | Naproxen | Naproxen | PD-Rx Pharmaceuticals, In | ANDA | Current |
| 43063-650 | Naproxen | Naproxen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-650 | Naproxen | Naproxen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-650 | Naproxen | Naproxen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-650 | Naproxen | Naproxen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-650 | Naproxen | Naproxen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-650 | Naproxen | Naproxen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-650 | Naproxen | Naproxen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43353-506 | Naproxen | Naproxen | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 50090-0468 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-0468 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-0468 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-0472 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-0478 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-0478 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-0478 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-0478 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-0480 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-0480 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-3036 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-3036 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-3036 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-3036 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-3041 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-3041 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-3041 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-3055 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-3055 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-3055 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-3055 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-4636 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-4637 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-4638 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-4638 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-4752 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-4752 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50090-4752 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 50268-594 | Naproxen | Naproxen | AvPAK | ANDA | Current |
| 50268-594 | Naproxen | Naproxen | AvPAK | ANDA | Current |
| 50268-594 | Naproxen | Naproxen | AvPAK | ANDA | Current |
| 50268-594 | Naproxen | Naproxen | AvPAK | ANDA | Current |
| 50268-595 | Naproxen | Naproxen | AvPAK | ANDA | Current |
| 50268-595 | Naproxen | Naproxen | AvPAK | ANDA | Current |