Application 075227
- Type
- ANDA
- Sponsor
- TEVA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NAPROXEN | NAPROXEN | TABLET, DELAYED RELEASE;ORAL | 375MG | No | No |
| 002 | NAPROXEN | NAPROXEN | TABLET, DELAYED RELEASE;ORAL | 500MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075227-001 | NAPROXEN | NAPROXEN | 375MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | |
| A075227-002 | NAPROXEN | NAPROXEN | 500MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075227-001 | AB |
| A075227-002 | 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 | A075227-001 | NAPROXEN | 375MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A075227-002 | NAPROXEN | 500MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A075227-001 | NAPROXEN | 375MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A075227-002 | NAPROXEN | 500MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075227-001 | NAPROXEN | 375MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075227-002 | NAPROXEN | 500MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075227-001 | NAPROXEN | 375MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075227-002 | NAPROXEN | 500MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075227-001 | NAPROXEN | 375MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075227-002 | NAPROXEN | 500MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075227-001 | NAPROXEN | 375MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075227-002 | NAPROXEN | 500MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075227-001 | NAPROXEN | 375MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075227-002 | NAPROXEN | 500MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075227-001 | NAPROXEN | 375MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075227-002 | NAPROXEN | 500MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075227-001 | NAPROXEN | 375MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075227-002 | NAPROXEN | 500MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075227-001 | NAPROXEN | 375MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075227-002 | NAPROXEN | 500MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075227-001 | NAPROXEN | 375MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075227-002 | NAPROXEN | 500MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075227-001 | NAPROXEN | 375MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075227-002 | NAPROXEN | 500MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075227-001 | NAPROXEN | 375MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075227-002 | NAPROXEN | 500MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075227-001 | NAPROXEN | 375MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075227-002 | NAPROXEN | 500MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075227-001 | NAPROXEN | 375MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075227-002 | NAPROXEN | 500MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A075227-001 | NAPROXEN | 375MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A075227-002 | NAPROXEN | 500MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075227-001 | NAPROXEN | 375MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075227-002 | NAPROXEN | 500MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A075227-001 | NAPROXEN | 375MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A075227-002 | NAPROXEN | 500MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A075227-001 | NAPROXEN | 375MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A075227-002 | NAPROXEN | 500MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A075227-001 | NAPROXEN | 375MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A075227-002 | NAPROXEN | 500MG | TABLET, DELAYED RELEASE / ORAL | AB | 1998-06-30 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A075227-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A075227-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A075227-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A075227-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A075227-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075227-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075227-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075227-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075227-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075227-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075227-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075227-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075227-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075227-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075227-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075227-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075227-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075227-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075227-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075227-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075227-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075227-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075227-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075227-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075227-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A075227-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075227-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A075227-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075227-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A075227-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A075227-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A075227-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075227-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A075227-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A075227-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A075227-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A075227-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A075227-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A075227-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A075227-002 | AB | 1 | 74a2ff9319b5… |
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 | Bryant Ranch Prepack | 1fe9a6fc-940e-4a18-b3e9-b204fd67f263 | 2024-09-03 | Boxed warning, Warnings, Adverse reactions | Naproxen NAPROXEN |
| Naproxen | NAPROXEN | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 205b1159-06e5-0d48-e063-6294a90acbd8 | 2024-08-23 | Boxed warning, Warnings, Adverse reactions | Naproxen NAPROXEN |
| Naproxen | NAPROXEN | Bryant Ranch Prepack | a4f31070-4ee1-4d64-8b1d-40b9011e124b | 2024-08-20 | Boxed warning, Warnings, Adverse reactions | Naproxen NAPROXEN |
| Naproxen | NAPROXEN | NuCare Pharmaceuticals,Inc. | 5e873524-f9fb-fe2d-e053-2991aa0aa0a5 | 2024-08-14 | Boxed warning, Warnings, Adverse reactions | Naproxen NAPROXEN |
| Naproxen | NAPROXEN | NuCare Pharmaceuticals, Inc. | 46dd3908-6feb-4f50-e054-00144ff88e88 | 2024-08-14 | Boxed warning, Warnings, Adverse reactions | Naproxen NAPROXEN |
| Naproxen | NAPROXEN | NuCare Pharmaceuticals, Inc. | 3e8bcc59-dab1-1b4c-e054-00144ff88e88 | 2024-08-13 | Boxed warning, Warnings, Adverse reactions | Naproxen NAPROXEN |
| NAPROXEN | NAPROXEN | NuCare Pharmaceuticals,Inc. | 5487dee2-5c37-4348-e054-00144ff8d46c | 2024-07-17 | Warnings | NAPROXEN NAPROXEN |
| NAPROXEN | NAPROXEN | NuCare Pharmaceuticals,Inc. | 71d4a048-ca50-73db-e053-2a95a90ad465 | 2024-06-10 | Warnings | NAPROXEN NAPROXEN |
| NAPROXEN | NAPROXEN | NuCare Pharmaceuticals,Inc. | 69366b55-2687-17a4-e053-2a91aa0a65b3 | 2024-06-07 | NAPROXEN NAPROXEN | |
| Naproxen | NAPROXEN | Bryant Ranch Prepack | 74134b90-d4c7-41bd-a1bd-2ac168db596f | 2024-04-30 | Boxed warning, Warnings, Adverse reactions | Naproxen NAPROXEN |
| Naproxen | NAPROXEN | Advanced Rx Pharmacy of Tennessee, LLC | 1431b769-5535-78d6-e063-6394a90a8423 | 2024-03-21 | Boxed warning, Warnings, Adverse reactions | Naproxen NAPROXEN |
| Naproxen | NAPROXEN | Asclemed USA, Inc. | 5a48c0d4-37bf-4c26-a9a7-5c67ff2adb4b | 2024-03-19 | Boxed warning, Warnings, Adverse reactions | Naproxen NAPROXEN |
| Naproxen | NAPROXEN | Medsource Pharmaceuticals | 12648efc-3be8-a915-e063-6394a90a3620 | 2024-02-27 | Boxed warning, Warnings, Adverse reactions | Naproxen NAPROXEN |
| Naproxen | NAPROXEN | Bryant Ranch Prepack | 1cdcaba5-5550-40f6-94cc-b0a98cc17d3c | 2024-01-11 | Boxed warning, Warnings, Adverse reactions | Naproxen NAPROXEN |
| Naproxen | NAPROXEN | Bryant Ranch Prepack | d564f52d-171c-4e7d-974c-3a0e192e6c12 | 2024-01-11 | Boxed warning, Warnings, Adverse reactions | Naproxen NAPROXEN |
| Naproxen | NAPROXEN | A-S Medication Solutions | f91c1a6b-b256-42e1-9da0-5f1975dec6ce | 2023-12-27 | Boxed warning, Warnings, Adverse reactions | Naproxen NAPROXEN |
| Naproxen | NAPROXEN | A-S Medication Solutions | a8b54258-84e7-41e8-9e51-137a3f442e6b | 2023-10-23 | Boxed warning, Warnings, Adverse reactions | Naproxen NAPROXEN |
| Naproxen | NAPROXEN | A-S Medication Solutions | 80233fa5-f8b4-42d5-a8c9-4a1d8fd4aba4 | 2023-10-01 | Boxed warning, Warnings, Adverse reactions | Naproxen NAPROXEN |
| Naproxen | NAPROXEN | A-S Medication Solutions | 50c52976-9e04-4a5e-9f21-aca3ea5c2924 | 2023-09-06 | Boxed warning, Warnings, Adverse reactions | Naproxen NAPROXEN |
| Naproxen | NAPROXEN | A-S Medication Solutions | d801ba16-e2ec-4bb2-8cff-32388634b35a | 2023-09-06 | Boxed warning, Warnings, Adverse reactions | Naproxen NAPROXEN |
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 |
|---|---|---|---|---|---|
| 0093-1005 | Naproxen | Naproxen | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-1005 | Naproxen | Naproxen | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-1005 | Naproxen | Naproxen | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-1005 | Naproxen | Naproxen | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-1006 | Naproxen | Naproxen | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-1006 | Naproxen | Naproxen | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-1006 | Naproxen | Naproxen | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-1006 | Naproxen | Naproxen | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 21695-343 | Naproxen | Naproxen | Rebel Distributors Corp | ANDA | Current |
| 33261-082 | Naproxen | Naproxen | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-083 | Naproxen | Naproxen | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 45865-867 | Naproxen | Naproxen | medsource pharmaceuticals | ANDA | Current |
| 45865-914 | Naproxen | Naproxen | medsource pharmaceuticals | ANDA | Current |
| 45865-914 | Naproxen | Naproxen | medsource pharmaceuticals | ANDA | Current |
| 49999-897 | Naproxen | Naproxen | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 50090-0608 | Naproxen | Naproxen | A-S Medication Solutions | ANDA | Current |
| 52959-516 | Naproxen | Naproxen | H.J. Harkins Company, Inc. | ANDA | Current |
| 55289-307 | Naproxen | Naproxen | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 63629-3795 | Naproxen | Naproxen | Bryant Ranch Prepack | ANDA | Current |
| 68151-2609 | Naproxen | Naproxen | Carilion Materials Management | ANDA | Current |
| 68788-6908 | Naproxen | Naproxen | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6908 | Naproxen | Naproxen | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6908 | Naproxen | Naproxen | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7072 | Naproxen | Naproxen | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7072 | Naproxen | Naproxen | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7072 | Naproxen | Naproxen | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-1064 | Naproxen | Naproxen | REMEDYREPACK INC. | ANDA | Current |
| 70518-1064 | Naproxen | Naproxen | REMEDYREPACK INC. | ANDA | Current |
| 71205-469 | Naproxen | Naproxen | Proficient Rx LP | ANDA | Current |
| 71205-469 | Naproxen | Naproxen | Proficient Rx LP | ANDA | Current |
| 71205-469 | Naproxen | Naproxen | Proficient Rx LP | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 30804 | ORIG | 1998-06-30 |