Application 078420
- Type
- ANDA
- Sponsor
- SCIEGEN PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NABUMETONE | NABUMETONE | TABLET;ORAL | 500MG | No | No |
| 002 | NABUMETONE | NABUMETONE | TABLET;ORAL | 750MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078420-001 | NABUMETONE | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | |
| A078420-002 | NABUMETONE | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078420-001 | AB |
| A078420-002 | 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 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A078420-001 | NABUMETONE | 500MG | TABLET / ORAL | AB | 2008-09-24 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A078420-002 | NABUMETONE | 750MG | TABLET / ORAL | AB | 2008-09-24 | 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 | A078420-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A078420-002 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A078420-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A078420-002 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A078420-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078420-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078420-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078420-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078420-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078420-002 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078420-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078420-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078420-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078420-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078420-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078420-002 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078420-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078420-002 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078420-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078420-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078420-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078420-002 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A078420-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A078420-002 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078420-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078420-002 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078420-001 | AB | 1 | 301d65b070ca… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078420-002 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078420-001 | AB | 1 | 1e350fbaab3a… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078420-002 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A078420-001 | AB | 1 | 8072bd15b7f6… |
| 2024-05-31 18:47 UTC | 2024-05 | A078420-002 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078420-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A078420-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A078420-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A078420-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A078420-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A078420-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A078420-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A078420-002 | 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 |
|---|---|---|---|---|---|---|
| Nabumetone | NABUMETONE | PD-Rx Pharmaceuticals, Inc. | 69620c53-b37a-45b9-b560-221bbcd98fda | 2025-02-04 | Boxed warning, Warnings, Adverse reactions | 078420 ANDA078420 72789-040 |
| NABUMETONE | NABUMETONE | direct rx | a8600b12-f180-0b27-e053-2995a90acbd9 | 2025-01-17 | Boxed warning, Warnings, Adverse reactions | 078420 ANDA078420 72189-072 72189-184 |
| Nabumetone | NABUMETONE | ScieGen Pharmaceuticals Inc | 80c6888d-03b4-44f3-b94d-bcf5154ceae5 | 2025-01-13 | Boxed warning, Warnings, Adverse reactions | 078420 ANDA078420 50228-466 50228-465 |
| Nabumetone | NABUMETONE | Advanced Rx of Tennessee, LLC | af9994ac-6687-2df2-e053-2995a90a959a | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 078420 ANDA078420 |
| Nabumetone | NABUMETONE | Advanced Rx Pharmacy of Tennessee, LLC | b43db4aa-6013-3942-e053-2a95a90a5189 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 078420 ANDA078420 |
| Nabumetone | NABUMETONE | Quality Care Products, LLC | da259c7c-6f1e-403c-b42b-596d53b61fe5 | 2024-12-18 | Boxed warning, Warnings, Adverse reactions | 078420 ANDA078420 55700-840 |
| Nabumetone | NABUMETONE | Quality Care Products, LLC | 065fdacc-739e-4b46-bebc-044b5c11bbbb | 2024-12-18 | Boxed warning, Warnings, Adverse reactions | 078420 ANDA078420 55700-845 |
| Nabumetone | NABUMETONE | A-S Medication Solutions | 26037234-daca-4f1a-a7a7-0871f77283f0 | 2024-11-13 | Boxed warning, Warnings, Adverse reactions | 078420 ANDA078420 50090-5294 |
| Nabumetone | NABUMETONE | A-S Medication Solutions | d997d125-dfc5-4cc5-b7a6-03f5a7248d14 | 2024-10-25 | Boxed warning, Warnings, Adverse reactions | 078420 ANDA078420 50090-6167 |
| Nabumetone | NABUMETONE | Westminster Pharmaceuticals, LLC | 264df44a-e294-4d9b-9113-92859cb08c20 | 2024-08-30 | Boxed warning, Warnings, Adverse reactions | 078420 ANDA078420 69367-242 69367-241 |
| Nabumetone | NABUMETONE | Bryant Ranch Prepack | 62f2e0bf-e5c8-480c-ac5e-401ced3bbc67 | 2024-08-27 | Boxed warning, Warnings, Adverse reactions | 078420 ANDA078420 71335-1391 |
| Nabumetone | NABUMETONE | Proficient Rx LP | 7a1643bf-6627-4b12-8246-6acc40517cf2 | 2022-05-01 | Boxed warning, Warnings, Adverse reactions | 078420 ANDA078420 71205-977 71205-978 |
| Nabumetone | NABUMETONE | Proficient Rx LP | f4392863-ed3f-4fbd-8260-49827609aa2e | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | 078420 ANDA078420 71205-530 |
| Nabumetone | NABUMETONE | Asclemed USA, Inc. | 04a71deb-2c9d-436c-a574-e5991b6a5248 | 2022-03-07 | Boxed warning, Warnings, Adverse reactions | 078420 ANDA078420 |
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 |
|---|---|---|---|---|---|
| 45865-111 | Nabumetone | Nabumetone | Medsource Pharmaceuticals | ANDA | Current |
| 50090-5294 | Nabumetone | Nabumetone | A-S Medication Solutions | ANDA | Current |
| 50090-5294 | Nabumetone | Nabumetone | A-S Medication Solutions | ANDA | Current |
| 50090-5294 | Nabumetone | Nabumetone | A-S Medication Solutions | ANDA | Current |
| 50090-6167 | Nabumetone | Nabumetone | A-S Medication Solutions | ANDA | Current |
| 50228-465 | Nabumetone | Nabumetone | ScieGen Pharmaceuticals Inc | ANDA | Current |
| 50228-465 | Nabumetone | Nabumetone | ScieGen Pharmaceuticals Inc | ANDA | Current |
| 50228-465 | Nabumetone | Nabumetone | ScieGen Pharmaceuticals Inc | ANDA | Current |
| 50228-465 | Nabumetone | Nabumetone | ScieGen Pharmaceuticals Inc | ANDA | Current |
| 50228-465 | Nabumetone | Nabumetone | ScieGen Pharmaceuticals Inc | ANDA | Current |
| 50228-466 | Nabumetone | Nabumetone | ScieGen Pharmaceuticals Inc | ANDA | Current |
| 50228-466 | Nabumetone | Nabumetone | ScieGen Pharmaceuticals Inc | ANDA | Current |
| 50228-466 | Nabumetone | Nabumetone | ScieGen Pharmaceuticals Inc | ANDA | Current |
| 50228-466 | Nabumetone | Nabumetone | ScieGen Pharmaceuticals Inc | ANDA | Current |
| 50228-466 | Nabumetone | Nabumetone | ScieGen Pharmaceuticals Inc | ANDA | Current |
| 53002-6960 | Nabumetone | Nabumetone | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 55700-840 | Nabumetone | Nabumetone | Quality Care Products, LLC | ANDA | Current |
| 55700-840 | Nabumetone | Nabumetone | Quality Care Products, LLC | ANDA | Current |
| 55700-840 | Nabumetone | Nabumetone | Quality Care Products, LLC | ANDA | Current |
| 55700-845 | Nabumetone | Nabumetone | Quality Care Products, LLC | ANDA | Current |
| 55700-845 | Nabumetone | Nabumetone | Quality Care Products, LLC | ANDA | Current |
| 55700-845 | Nabumetone | Nabumetone | Quality Care Products, LLC | ANDA | Current |
| 60760-368 | Nabumetone | Nabumetone | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-368 | Nabumetone | Nabumetone | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-369 | Nabumetone | Nabumetone | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-369 | Nabumetone | Nabumetone | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-369 | Nabumetone | Nabumetone | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 63629-8506 | Nabumetone | Nabumetone | Bryant Ranch Prepack | ANDA | Current |
| 63629-8506 | Nabumetone | Nabumetone | Bryant Ranch Prepack | ANDA | Current |
| 63629-8506 | Nabumetone | Nabumetone | Bryant Ranch Prepack | ANDA | Current |
| 63629-8508 | Nabumetone | Nabumetone | Bryant Ranch Prepack | ANDA | Current |
| 63629-8508 | Nabumetone | Nabumetone | Bryant Ranch Prepack | ANDA | Current |
| 63629-8508 | Nabumetone | Nabumetone | Bryant Ranch Prepack | ANDA | Current |
| 63629-8509 | Nabumetone | Nabumetone | Bryant Ranch Prepack | ANDA | Current |
| 63629-8509 | Nabumetone | Nabumetone | Bryant Ranch Prepack | ANDA | Current |
| 63629-8509 | Nabumetone | Nabumetone | Bryant Ranch Prepack | ANDA | Current |
| 63629-8510 | Nabumetone | Nabumetone | Bryant Ranch Prepack | ANDA | Current |
| 63629-8510 | Nabumetone | Nabumetone | Bryant Ranch Prepack | ANDA | Current |
| 63629-8510 | Nabumetone | Nabumetone | Bryant Ranch Prepack | ANDA | Current |
| 68071-5166 | Nabumetone | Nabumetone | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-5166 | Nabumetone | Nabumetone | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7597 | Nabumetone | Nabumetone | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7597 | Nabumetone | Nabumetone | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7765 | Nabumetone | Nabumetone | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7765 | Nabumetone | Nabumetone | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7765 | Nabumetone | Nabumetone | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 69367-241 | Nabumetone | Nabumetone | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-241 | Nabumetone | Nabumetone | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-241 | Nabumetone | Nabumetone | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-241 | Nabumetone | Nabumetone | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-242 | Nabumetone | Nabumetone | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-242 | Nabumetone | Nabumetone | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-242 | Nabumetone | Nabumetone | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 69367-242 | Nabumetone | Nabumetone | Westminster Pharmaceuticals, LLC | ANDA | Current |
| 70934-847 | Nabumetone | Nabumetone | Denton Pharma, Inc. DBA Northwind Pharmaceuticals | ANDA | Current |
| 71205-530 | Nabumetone | Nabumetone | Proficient Rx LP | ANDA | Current |
| 71205-530 | Nabumetone | Nabumetone | Proficient Rx LP | ANDA | Current |
| 71205-977 | Nabumetone | Nabumetone | Proficient Rx LP | ANDA | Current |
| 71205-977 | Nabumetone | Nabumetone | Proficient Rx LP | ANDA | Current |
| 71205-977 | Nabumetone | Nabumetone | Proficient Rx LP | ANDA | Current |
| 71205-978 | Nabumetone | Nabumetone | Proficient Rx LP | ANDA | Current |
| 71205-978 | Nabumetone | Nabumetone | Proficient Rx LP | ANDA | Current |
| 71205-978 | Nabumetone | Nabumetone | Proficient Rx LP | ANDA | Current |
| 71335-1391 | Nabumetone | Nabumetone | Bryant Ranch Prepack | ANDA | Current |
| 71335-1391 | Nabumetone | Nabumetone | Bryant Ranch Prepack | ANDA | Current |
| 71335-1391 | Nabumetone | Nabumetone | Bryant Ranch Prepack | ANDA | Current |
| 71335-1559 | Nabumetone | Nabumetone | Bryant Ranch Prepack | ANDA | Current |
| 71335-1559 | Nabumetone | Nabumetone | Bryant Ranch Prepack | ANDA | Current |
| 72189-072 | NABUMETONE | NABUMETONE | direct rx | ANDA | Current |
| 72189-072 | NABUMETONE | NABUMETONE | direct rx | ANDA | Current |
| 72189-072 | NABUMETONE | NABUMETONE | direct rx | ANDA | Current |
| 72189-072 | NABUMETONE | NABUMETONE | direct rx | ANDA | Current |
| 72189-072 | NABUMETONE | NABUMETONE | direct rx | ANDA | Current |
| 72189-072 | NABUMETONE | NABUMETONE | direct rx | ANDA | Current |
| 72189-184 | NABUMETONE | NABUMETONE | direct rx | ANDA | Current |
| 72189-184 | NABUMETONE | NABUMETONE | direct rx | ANDA | Current |
| 72189-184 | NABUMETONE | NABUMETONE | direct rx | ANDA | Current |
| 72189-184 | NABUMETONE | NABUMETONE | direct rx | ANDA | Current |
| 72189-184 | NABUMETONE | NABUMETONE | direct rx | ANDA | Current |
| 72789-040 | Nabumetone | Nabumetone | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |