Application 091416
- Type
- ANDA
- Sponsor
- MARKSANS PHARMA
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 |
|---|---|---|---|---|---|---|---|
| A091416-001 | NAPROXEN | NAPROXEN | 250MG | TABLET / ORAL | AB | 2011-02-14 | |
| A091416-002 | NAPROXEN | NAPROXEN | 375MG | TABLET / ORAL | AB | 2011-02-14 | |
| A091416-003 | NAPROXEN | NAPROXEN | 500MG | TABLET / ORAL | AB | 2011-02-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A091416-001 | AB |
| A091416-002 | AB |
| A091416-003 | 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 | A091416-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2011-02-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091416-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2011-02-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091416-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2011-02-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091416-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2011-02-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091416-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2011-02-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091416-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2011-02-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091416-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2011-02-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091416-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2011-02-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091416-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2011-02-14 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091416-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2011-02-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091416-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2011-02-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091416-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2011-02-14 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091416-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2011-02-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091416-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2011-02-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091416-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2011-02-14 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091416-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2011-02-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091416-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2011-02-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091416-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2011-02-14 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091416-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2011-02-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091416-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2011-02-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091416-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2011-02-14 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091416-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2011-02-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091416-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2011-02-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091416-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2011-02-14 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091416-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2011-02-14 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091416-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2011-02-14 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091416-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2011-02-14 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091416-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2011-02-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091416-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2011-02-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091416-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2011-02-14 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091416-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2011-02-14 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091416-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2011-02-14 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091416-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2011-02-14 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091416-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2011-02-14 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091416-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2011-02-14 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091416-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2011-02-14 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091416-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2011-02-14 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091416-002 | NAPROXEN | 375MG | TABLET / ORAL | AB | 2011-02-14 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091416-003 | NAPROXEN | 500MG | TABLET / ORAL | AB | 2011-02-14 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A091416-001 | NAPROXEN | 250MG | TABLET / ORAL | AB | 2011-02-14 | 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 | A091416-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091416-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A091416-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091416-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091416-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091416-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A091416-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091416-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A091416-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091416-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091416-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091416-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091416-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091416-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091416-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091416-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091416-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091416-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091416-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091416-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091416-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091416-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091416-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091416-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091416-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091416-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091416-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A091416-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A091416-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A091416-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091416-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091416-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091416-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091416-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091416-002 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091416-003 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091416-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091416-002 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091416-003 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A091416-001 | 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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 10544-111 | NAPROXEN | NAPROXEN | Blenheim Pharmacal, Inc. | ANDA | Current |
| 25000-138 | Naproxen | Naproxen | MARKSANS PHARMA LIMITED | ANDA | Current |
| 25000-138 | Naproxen | Naproxen | MARKSANS PHARMA LIMITED | ANDA | Current |
| 25000-138 | Naproxen | Naproxen | MARKSANS PHARMA LIMITED | ANDA | Current |
| 25000-138 | Naproxen | Naproxen | MARKSANS PHARMA LIMITED | ANDA | Current |
| 25000-139 | Naproxen | Naproxen | MARKSANS PHARMA LIMITED | ANDA | Current |
| 25000-139 | Naproxen | Naproxen | MARKSANS PHARMA LIMITED | ANDA | Current |
| 25000-139 | Naproxen | Naproxen | MARKSANS PHARMA LIMITED | ANDA | Current |
| 25000-139 | Naproxen | Naproxen | MARKSANS PHARMA LIMITED | ANDA | Current |
| 25000-140 | Naproxen | Naproxen | MARKSANS PHARMA LIMITED | ANDA | Current |
| 25000-140 | Naproxen | Naproxen | MARKSANS PHARMA LIMITED | ANDA | Current |
| 25000-140 | Naproxen | Naproxen | MARKSANS PHARMA LIMITED | ANDA | Current |
| 25000-140 | Naproxen | Naproxen | MARKSANS PHARMA LIMITED | ANDA | Current |
| 42708-140 | NAPROXEN | NAPROXEN | QPharma Inc | ANDA | Current |
| 43063-920 | NAPROXEN | NAPROXEN | PD-Rx Pharmaceuticals, In | ANDA | Current |
| 43063-920 | NAPROXEN | NAPROXEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-920 | NAPROXEN | NAPROXEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-920 | NAPROXEN | NAPROXEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-920 | NAPROXEN | NAPROXEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-920 | NAPROXEN | NAPROXEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-920 | NAPROXEN | NAPROXEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-920 | NAPROXEN | NAPROXEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-920 | NAPROXEN | NAPROXEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-920 | NAPROXEN | NAPROXEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-937 | NAPROXEN | NAPROXEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-937 | NAPROXEN | NAPROXEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-937 | NAPROXEN | NAPROXEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-937 | NAPROXEN | NAPROXEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-937 | NAPROXEN | NAPROXEN | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 45865-581 | NAPROXEN | NAPROXEN | medsource pharmaceuticals | ANDA | Current |
| 49483-617 | NAPROXEN | NAPROXEN | TIME CAP LABORATORIES | ANDA | Current |
| 49483-618 | NAPROXEN | NAPROXEN | TIME CAP LABORATORIES | ANDA | Current |
| 49483-619 | NAPROXEN | NAPROXEN | TIME CAP LABORATORIES | ANDA | Current |
| 50436-0618 | NAPROXEN | NAPROXEN | Unit Dose Services | ANDA | Current |
| 52605-138 | NAPROXEN | NAPROXEN | Polygen Pharmaceuticals LLC | ANDA | Current |
| 52605-139 | NAPROXEN | NAPROXEN | Polygen Pharmaceuticals LLC | ANDA | Current |
| 52605-140 | NAPROXEN | NAPROXEN | Polygen Pharmaceuticals LLC | ANDA | Current |
| 52959-193 | NAPROXEN | NAPROXEN | H.J. Harkins Company., Inc. | ANDA | Current |
| 53002-3110 | NAPROXEN | NAPROXEN | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-3110 | NAPROXEN | NAPROXEN | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 60760-561 | NAPROXEN | NAPROXEN | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 66336-815 | NAPROXEN | NAPROXEN | Dispensing Solutions, Inc. | ANDA | Current |
| 67296-1609 | NAPROXEN | NAPROXEN | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1609 | NAPROXEN | NAPROXEN | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1609 | NAPROXEN | NAPROXEN | RedPharm Drug, Inc. | ANDA | Current |
| 68071-3345 | NAPROXEN | NAPROXEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3345 | NAPROXEN | NAPROXEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4006 | NAPROXEN | NAPROXEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4006 | NAPROXEN | NAPROXEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4381 | NAPROXEN | NAPROXEN | NuCare Pharmaceuticals,In | ANDA | Current |
| 68071-4381 | NAPROXEN | NAPROXEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4381 | NAPROXEN | NAPROXEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4510 | NAPROXEN | NAPROXEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4510 | NAPROXEN | NAPROXEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4510 | NAPROXEN | NAPROXEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4995 | NAPROXEN | NAPROXEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4995 | NAPROXEN | NAPROXEN | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-6998 | NAPROXEN | NAPROXEN | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7711 | NAPROXEN | NAPROXEN | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7711 | NAPROXEN | NAPROXEN | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7711 | NAPROXEN | NAPROXEN | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 69150-138 | NAPROXEN | NAPROXEN | Biomes Pharmaceuticals | ANDA | Current |
| 69150-139 | NAPROXEN | NAPROXEN | Biomes Pharmaceuticals | ANDA | Current |
| 69150-140 | NAPROXEN | NAPROXEN | Biomes Pharmaceuticals | ANDA | Current |
| 70518-2428 | NAPROXEN | NAPROXEN | REMEDYREPACK INC. | ANDA | Current |
| 70518-2428 | NAPROXEN | NAPROXEN | REMEDYREPACK INC. | ANDA | Current |
| 70518-2428 | NAPROXEN | NAPROXEN | REMEDYREPACK INC. | ANDA | Current |
| 70934-124 | NAPROXEN | NAPROXEN | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-124 | NAPROXEN | NAPROXEN | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-124 | NAPROXEN | NAPROXEN | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-455 | NAPROXEN | NAPROXEN | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 70934-455 | NAPROXEN | NAPROXEN | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71335-0255 | NAPROXEN | NAPROXEN | Bryant Ranch Prepack | ANDA | Current |
| 71335-0255 | NAPROXEN | NAPROXEN | Bryant Ranch Prepack | ANDA | Current |
| 71335-0255 | NAPROXEN | NAPROXEN | Bryant Ranch Prepack | ANDA | Current |
| 71335-0973 | NAPROXEN | NAPROXEN | Bryant Ranch Prepack | ANDA | Current |
| 71335-0973 | NAPROXEN | NAPROXEN | Bryant Ranch Prepack | ANDA | Current |
| 71335-0973 | NAPROXEN | NAPROXEN | Bryant Ranch Prepack | ANDA | Current |
| 71335-0973 | NAPROXEN | NAPROXEN | Bryant Ranch Prepack | ANDA | Current |
| 71610-436 | NAPROXEN | NAPROXEN | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |