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| N207233-001 | VIVLODEX | MELOXICAM | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | |
| N207233-002 | VIVLODEX | MELOXICAM | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 |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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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UTC | 2026-02 | N207233-001 | VIVLODEX | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | 011fe1cb6892… | |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… | |
| 2022-03-09 01:35 UTC | 2022-03 | 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 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | 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 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N207233-001 | VIVLODEX | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N207233-002 | VIVLODEX | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | RLD | 2015-10-22 | 782e0a99824c… |
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 |
|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N207233-001 | 9526734 | 2033-03-31 | Drug product | 2016-12-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N207233-001 | 9649318 | 2035-03-31 | Drug product | 2017-05-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N207233-001 | 9808468 | 2035-03-31 | U-2165 | 2017-11-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N207233-001 | 9808468 | 2035-03-31 | U-2160 | 2017-11-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N207233-002 | 9526734 | 2033-03-31 | Drug product | 2016-12-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N207233-002 | 9649318 | 2035-03-31 | Drug product | 2017-05-16 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N207233-002 | 9808468 | 2035-03-31 | U-2160 | 2017-11-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N207233-002 | 9808468 | 2035-03-31 | U-2165 | 2017-11-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N207233-001 | 9526734 | 2033-03-31 | Drug product | 2016-12-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N207233-001 | 9649318 | 2035-03-31 | Drug product | 2017-05-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N207233-001 | 9808468 | 2035-03-31 | U-2165 | 2017-11-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N207233-001 | 9808468 | 2035-03-31 | U-2160 | 2017-11-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N207233-002 | 9526734 | 2033-03-31 | Drug product | 2016-12-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N207233-002 | 9649318 | 2035-03-31 | Drug product | 2017-05-16 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N207233-002 | 9808468 | 2035-03-31 | U-2160 | 2017-11-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N207233-002 | 9808468 | 2035-03-31 | U-2165 | 2017-11-22 | b8a1b40f171c… |
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 | REMEDYREPACK INC. | f8c35ea4-d6ac-40c7-8f35-864fd1ec75d2 | 2026-07-27 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| Meloxicam | MELOXICAM | Advanced Rx of Tennessee, LLC | 5488ccc1-e416-e5d7-e063-6294a90a6cb8 | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| Meloxicam | MELOXICAM | Advanced Rx of Tennessee, LLC | 548ec3b7-2b6d-cd9e-e063-6394a90a78ff | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| Meloxicam | MELOXICAM | Advanced Rx of Tennessee, LLC | 548ef3ed-ab67-ec85-e063-6294a90ab1da | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| QAMZOVA | MELOXICAM | Nanjing Delova Biotech Co., Ltd. | 385fd779-1be1-49ae-8213-750b96ecc997 | 2026-07-16 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| meloxicam | MELOXICAM | Coupler LLC | 56440abd-80f4-7b8d-e063-6394a90a2a91 | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| MELOXICAM | MELOXICAM | REMEDYREPACK INC. | 385b7cf4-976a-4a58-9ebc-def8b6e78b75 | 2026-07-09 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| meloxicam | MELOXICAM | HAWAII REPACK, INC. | 68b50c82-7130-428a-884c-98576887e99a | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| Meloxicam | MELOXICAM | Terrain Pharmaceuticals, Inc. | b603255e-1fcf-42ec-ab62-9aa321cb7ac6 | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| meloxicam | MELOXICAM | REMEDYREPACK INC. | 5d153147-f1c8-4624-8028-fe84680d7143 | 2026-06-25 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| MELOXICAM | MELOXICAM | REMEDYREPACK INC. | cdd282df-572f-42a7-a1c6-a00e1bb4573d | 2026-06-24 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| meloxicam | MELOXICAM | REMEDYREPACK INC. | 3e8a6283-1e1b-4199-ac73-f42255c7e907 | 2026-06-22 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| meloxicam | MELOXICAM | REMEDYREPACK INC. | ffaf1db4-25a9-48d1-a624-242f9d8e14c7 | 2026-06-22 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| meloxicam | MELOXICAM | St. Mary's Medical Park Pharmacy | b710b959-a64d-a631-e053-2995a90a2177 | 2026-06-20 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| meloxicam | MELOXICAM | Preferred Pharmaceuticals, Inc. | 66bc3f93-a73b-476c-83d4-7354d2e18575 | 2026-06-15 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| meloxicam | MELOXICAM | Preferred Pharmaceuticals Inc. | e0deb1f7-b575-463f-a3f8-304cc1936075 | 2026-06-15 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| MELOXICAM | MELOXICAM | Redpharm Drug | 5407aded-9f84-72ce-e063-6394a90ae672 | 2026-06-12 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| MELOXICAM | MELOXICAM | St. Mary's Medical Park Pharmacy | fbe71312-0f9d-47c1-e053-6394a90a63a1 | 2026-06-02 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| meloxicam | MELOXICAM | St. Mary's Medical Park Pharmacy | 60c954d5-bd5a-33f9-e053-2a91aa0ab597 | 2026-06-01 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| Meloxicam | MELOXICAM | Emerald Therapeutics, LLC | 55af77dd-2abc-49a6-990c-399d5a5e7a91 | 2026-05-29 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
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 |