Application 207233
- Type
- NDA
- Sponsor
- ZYLA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VIVLODEX | MELOXICAM | CAPSULE;ORAL | 5MG | Yes | No |
| 002 | VIVLODEX | MELOXICAM | CAPSULE;ORAL | 10MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N207233-001 | VIVLODEX | MELOXICAM | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | |
| N207233-002 | VIVLODEX | MELOXICAM | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N207233-001 | 9526734 | 2033-03-31 | Drug product | 2016-12-30 | |
| N207233-001 | 9649318 | 2035-03-31 | Drug product | 2017-05-16 | |
| N207233-001 | 9808468 | 2035-03-31 | U-2160 | 2017-11-22 | |
| N207233-001 | 9808468 | 2035-03-31 | U-2165 | 2017-11-22 | |
| N207233-002 | 9526734 | 2033-03-31 | Drug product | 2016-12-30 | |
| N207233-002 | 9649318 | 2035-03-31 | Drug product | 2017-05-16 | |
| N207233-002 | 9808468 | 2035-03-31 | U-2160 | 2017-11-22 | |
| N207233-002 | 9808468 | 2035-03-31 | U-2165 | 2017-11-22 |
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| 2026-08 | N207233-001 | VIVLODEX | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N207233-002 | VIVLODEX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N207233-001 | VIVLODEX | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207233-002 | VIVLODEX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207233-001 | VIVLODEX | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207233-002 | VIVLODEX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207233-001 | VIVLODEX | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207233-002 | VIVLODEX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N207233-001 | VIVLODEX | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N207233-002 | VIVLODEX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N207233-001 | VIVLODEX | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N207233-002 | VIVLODEX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N207233-001 | VIVLODEX | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N207233-002 | VIVLODEX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N207233-001 | VIVLODEX | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N207233-002 | VIVLODEX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N207233-001 | VIVLODEX | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N207233-002 | VIVLODEX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N207233-001 | VIVLODEX | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N207233-002 | VIVLODEX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N207233-001 | VIVLODEX | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N207233-002 | VIVLODEX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N207233-001 | VIVLODEX | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N207233-002 | VIVLODEX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N207233-001 | VIVLODEX | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N207233-002 | VIVLODEX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N207233-001 | VIVLODEX | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N207233-002 | VIVLODEX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N207233-001 | VIVLODEX | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N207233-002 | VIVLODEX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N207233-001 | VIVLODEX | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N207233-002 | VIVLODEX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N207233-001 | VIVLODEX | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N207233-002 | VIVLODEX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N207233-001 | VIVLODEX | 5MG | CAPSULE / ORAL | RLD | 2015-10-22 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N207233-002 | VIVLODEX | 10MG | CAPSULE / ORAL | RLD | 2015-10-22 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N207233-001 | VIVLODEX | 5MG | CAPSULE / ORAL | RLD | 2015-10-22 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N207233-002 | VIVLODEX | 10MG | CAPSULE / ORAL | RLD | 2015-10-22 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N207233-001 | VIVLODEX | 5MG | CAPSULE / ORAL | RLD | 2015-10-22 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N207233-002 | VIVLODEX | 10MG | CAPSULE / ORAL | RLD, RS | 2015-10-22 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2020-11-12 02:37 UTC | 2020-11 | N207233-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N207233-002 | AB | 1 | c0c555d07b60… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N207233-001 | 9526734 | 2033-03-31 | Drug product | 2016-12-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N207233-001 | 9649318 | 2035-03-31 | Drug product | 2017-05-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N207233-001 | 9808468 | 2035-03-31 | U-2165 | 2017-11-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N207233-001 | 9808468 | 2035-03-31 | U-2160 | 2017-11-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N207233-002 | 9526734 | 2033-03-31 | Drug product | 2016-12-30 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N207233-002 | 9649318 | 2035-03-31 | Drug product | 2017-05-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N207233-002 | 9808468 | 2035-03-31 | U-2160 | 2017-11-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N207233-002 | 9808468 | 2035-03-31 | U-2165 | 2017-11-22 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N207233-001 | 9526734 | 2033-03-31 | Drug product | 2016-12-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207233-001 | 9649318 | 2035-03-31 | Drug product | 2017-05-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207233-001 | 9808468 | 2035-03-31 | U-2165 | 2017-11-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207233-001 | 9808468 | 2035-03-31 | U-2160 | 2017-11-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207233-002 | 9526734 | 2033-03-31 | Drug product | 2016-12-30 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207233-002 | 9649318 | 2035-03-31 | Drug product | 2017-05-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207233-002 | 9808468 | 2035-03-31 | U-2160 | 2017-11-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N207233-002 | 9808468 | 2035-03-31 | U-2165 | 2017-11-22 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207233-001 | 9526734 | 2033-03-31 | Drug product | 2016-12-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207233-001 | 9649318 | 2035-03-31 | Drug product | 2017-05-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207233-001 | 9808468 | 2035-03-31 | U-2165 | 2017-11-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207233-001 | 9808468 | 2035-03-31 | U-2160 | 2017-11-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207233-002 | 9526734 | 2033-03-31 | Drug product | 2016-12-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207233-002 | 9649318 | 2035-03-31 | Drug product | 2017-05-16 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207233-002 | 9808468 | 2035-03-31 | U-2160 | 2017-11-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N207233-002 | 9808468 | 2035-03-31 | U-2165 | 2017-11-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207233-001 | 9526734 | 2033-03-31 | Drug product | 2016-12-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207233-001 | 9649318 | 2035-03-31 | Drug product | 2017-05-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207233-001 | 9808468 | 2035-03-31 | U-2165 | 2017-11-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207233-001 | 9808468 | 2035-03-31 | U-2160 | 2017-11-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207233-002 | 9526734 | 2033-03-31 | Drug product | 2016-12-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207233-002 | 9649318 | 2035-03-31 | Drug product | 2017-05-16 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207233-002 | 9808468 | 2035-03-31 | U-2160 | 2017-11-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N207233-002 | 9808468 | 2035-03-31 | U-2165 | 2017-11-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N207233-001 | 9526734 | 2033-03-31 | Drug product | 2016-12-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N207233-001 | 9649318 | 2035-03-31 | Drug product | 2017-05-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N207233-001 | 9808468 | 2035-03-31 | U-2165 | 2017-11-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N207233-001 | 9808468 | 2035-03-31 | U-2160 | 2017-11-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N207233-002 | 9526734 | 2033-03-31 | Drug product | 2016-12-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N207233-002 | 9649318 | 2035-03-31 | Drug product | 2017-05-16 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N207233-002 | 9808468 | 2035-03-31 | U-2160 | 2017-11-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N207233-002 | 9808468 | 2035-03-31 | U-2165 | 2017-11-22 | 6a471c1ec25d… |
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 |
|---|---|---|---|---|---|---|
| MELOXICAM | MELOXICAM | Bryant Ranch Prepack | e5860527-f338-4073-9bb4-9f5f079469e7 | 2024-08-08 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| meloxicam | MELOXICAM | Bryant Ranch Prepack | 3e37bece-b23e-41ca-9557-5105087e273b | 2024-08-08 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| Meloxicam | MELOXICAM | Lupin Pharmaceuticals, Inc. | 06a401f0-4380-4081-86ed-a309a25abf6b | 2024-08-08 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| meloxicam | MELOXICAM | Unichem Pharmaceuticals (USA), Inc. | 5fe76337-eae5-4e5c-96ef-6cfa97983c6e | 2024-08-05 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| meloxicam | MELOXICAM | NuCare Pharmaceuticals, Inc. | 4925f194-c924-242c-e054-00144ff88e88 | 2024-07-16 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| meloxicam | MELOXICAM | NuCare Pharmaceuticals,Inc. | 630221ef-714e-6996-e053-2991aa0a586f | 2024-07-16 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| MELOXICAM | MELOXICAM | Proficient Rx LP | 3cc9741f-0574-485f-bbf5-027cb236736c | 2024-06-01 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| MELOXICAM | MELOXICAM | AiPing Pharmaceutical, Inc | f93806e1-88b8-4bcd-ac29-7642ab4d6cbd | 2024-05-02 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| meloxicam | MELOXICAM | A-S Medication Solutions | eb5834e0-c6db-4d0f-ae37-9ba2e1aabfdf | 2023-11-26 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| meloxicam | MELOXICAM | A-S Medication Solutions | bcfca8c6-bdba-4546-97be-1fc5601c7346 | 2023-09-19 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| MELOXICAM | MELOXICAM | NCS HealthCare of KY, LLC dba Vangard Labs | 108397e9-672d-4061-bb74-65818c782d61 | 2023-03-07 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| meloxicam | MELOXICAM | Asclemed USA, Inc. | 49367275-4bff-4e36-8a91-e59eb07aa15f | 2022-10-05 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| Meloxicam | MELOXICAM | Aphena Pharma Solutions - Tennessee, LLC | e1603665-bbce-48b3-9424-3646570ae9b8 | 2022-08-17 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| Meloxicam | MELOXICAM | Proficient Rx LP | b5d72a30-3d32-45ad-be81-3fe601d8912b | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| Meloxicam | MELOXICAM | Aphena Pharma Solutions - Tennessee, LLC | 432c3937-a4fe-4c92-8452-9ed2dd2cfc9a | 2022-03-03 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| Meloxicam | MELOXICAM | Aphena Pharma Solutions - Tennessee, LLC | 9392df66-a152-40e6-b43b-44dc46a23496 | 2021-08-10 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| meloxicam | MELOXICAM | Aphena Pharma Solutions - Tennessee, LLC | 10c3949c-0066-4b8a-8d35-937e1ce09bf8 | 2021-08-06 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| Meloxicam | MELOXICAM | Aphena Pharma Solutions - Tennessee, LLC | 8f43b954-d1cb-4210-b479-5292c446cc74 | 2021-05-20 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| meloxicam | MELOXICAM | Aphena Pharma Solutions - Tennessee, LLC | 966ae650-ad7d-4de1-ab06-54992408fcfd | 2021-03-11 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| Meloxicam | MELOXICAM | Aphena Pharma Solutions - Tennessee, LLC | 2a29daa9-74e5-4ed6-b5f1-ce04dc411b26 | 2020-07-20 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
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 |
|---|---|---|---|---|---|
| 42211-205 | Vivlodex | meloxicam | Iroko Pharmaceuticals, LL | NDA | Current |
| 42211-205 | Vivlodex | meloxicam | Iroko Pharmaceuticals, LLC | NDA | Current |
| 42211-206 | Vivlodex | meloxicam | Iroko Pharmaceuticals, LL | NDA | Current |
| 42211-206 | Vivlodex | meloxicam | Iroko Pharmaceuticals, LLC | NDA | Current |
| 69344-205 | Vivlodex | meloxicam | Egalet US Inc. | NDA | Current |
| 69344-205 | Vivlodex | meloxicam | Egalet US Inc. | NDA | Current |
| 69344-205 | Vivlodex | meloxicam | Egalet US Inc. | NDA | Current |
| 69344-206 | Vivlodex | meloxicam | Egalet US Inc. | NDA | Current |
| 69344-206 | Vivlodex | meloxicam | Egalet US Inc. | NDA | Current |
| 69344-206 | Vivlodex | meloxicam | Egalet US Inc. | NDA | Current |