Application 211210
- Type
- NDA
- Sponsor
- TERSERA THERAPS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | QMIIZ ODT | MELOXICAM | TABLET, ORALLY DISINTEGRATING;ORAL | 7.5MG | Yes | No |
| 002 | QMIIZ ODT | MELOXICAM | TABLET, ORALLY DISINTEGRATING;ORAL | 15MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N211210-001 | QMIIZ ODT | MELOXICAM | 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | |
| N211210-002 | QMIIZ ODT | MELOXICAM | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N211210-001 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | |
| N211210-002 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 |
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| 2026-08 | N211210-001 | QMIIZ ODT | 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N211210-002 | QMIIZ ODT | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N211210-001 | QMIIZ ODT | 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N211210-002 | QMIIZ ODT | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N211210-001 | QMIIZ ODT | 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N211210-002 | QMIIZ ODT | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N211210-001 | QMIIZ ODT | 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N211210-002 | QMIIZ ODT | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N211210-001 | QMIIZ ODT | 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N211210-002 | QMIIZ ODT | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N211210-001 | QMIIZ ODT | 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N211210-002 | QMIIZ ODT | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N211210-001 | QMIIZ ODT | 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N211210-002 | QMIIZ ODT | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N211210-001 | QMIIZ ODT | 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N211210-002 | QMIIZ ODT | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N211210-001 | QMIIZ ODT | 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N211210-002 | QMIIZ ODT | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N211210-001 | QMIIZ ODT | 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N211210-002 | QMIIZ ODT | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N211210-001 | QMIIZ ODT | 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N211210-002 | QMIIZ ODT | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N211210-001 | QMIIZ ODT | 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N211210-002 | QMIIZ ODT | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N211210-001 | QMIIZ ODT | 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N211210-002 | QMIIZ ODT | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N211210-001 | QMIIZ ODT | 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N211210-002 | QMIIZ ODT | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N211210-001 | QMIIZ ODT | 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N211210-002 | QMIIZ ODT | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N211210-001 | QMIIZ ODT | 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N211210-002 | QMIIZ ODT | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N211210-001 | QMIIZ ODT | 7.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N211210-002 | QMIIZ ODT | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N211210-001 | QMIIZ ODT | 7.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N211210-002 | QMIIZ ODT | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N211210-001 | QMIIZ ODT | 7.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N211210-002 | QMIIZ ODT | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N211210-001 | QMIIZ ODT | 7.5MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD | 2018-10-19 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N211210-002 | QMIIZ ODT | 15MG | TABLET, ORALLY DISINTEGRATING / ORAL | RLD, RS | 2018-10-19 | 74a2ff9319b5… |
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 | N211210-001 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N211210-002 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N211210-001 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N211210-002 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N211210-001 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N211210-002 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N211210-001 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N211210-002 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N211210-001 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N211210-002 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N211210-001 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N211210-002 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N211210-001 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N211210-002 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N211210-001 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N211210-002 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N211210-001 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N211210-002 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N211210-001 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N211210-002 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N211210-001 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N211210-002 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N211210-001 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N211210-002 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N211210-001 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N211210-002 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N211210-001 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N211210-002 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N211210-001 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N211210-002 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N211210-001 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N211210-002 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N211210-001 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N211210-002 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N211210-001 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N211210-002 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N211210-001 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N211210-002 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N211210-001 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N211210-002 | 8545879 | 2030-08-31 | Drug product | 2018-10-24 | 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 |
|---|---|---|---|---|---|---|
| meloxicam | MELOXICAM | PHOENIX RX LLC | 3ff222f1-3fe2-9591-e063-6394a90a349f | 2025-09-29 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| Meloxicam | MELOXICAM | American Health Packaging | 937ea2ca-6b8c-4c80-9926-f4de7c8f5643 | 2025-09-23 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| Meloxicam | MELOXICAM | Lupin Pharmaceuticals, Inc. | 43e2b0f3-cf34-4f51-aa93-39ed98cab449 | 2025-09-16 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| Meloxicam | MELOXICAM | AvPAK | ee8df8fa-d08a-8c8b-f048-813e5022a101 | 2025-09-16 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| meloxicam | MELOXICAM | PHOENIX RX LLC | 3ede6724-d9be-5b44-e063-6294a90afbaa | 2025-09-15 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| MELOXICAM | MELOXICAM | Cipla USA Inc. | bb83cd61-0a82-4fe0-b72e-5b715cbd656d | 2025-09-10 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| MELOXICAM | MELOXICAM | PHOENIX RX LLC | 3b1938e5-7a9e-b214-e063-6394a90a1270 | 2025-08-13 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| XIFYRM | MELOXICAM | Azurity Pharmaceuticals, Inc. | bf2b198c-0726-488a-b911-4fe394e4b56e | 2025-06-18 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| Meloxicam | MELOXICAM | ANI Pharmaceuticals, Inc. | ce9a8fd7-9bd2-4793-82f3-0fb8f0965d0f | 2025-06-10 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| MELOXICAM | MELOXICAM | Asclemed USA, Inc. | 6d7ede5a-c12e-4979-a47a-f3346ea5bc80 | 2025-05-02 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| Meloxicam | MELOXICAM | Carlsbad Technology, Inc. | 20871c7f-1e36-49ef-8e2b-70112430ca1e | 2025-05-02 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| Meloxicam | MELOXICAM | Bryant Ranch Prepack | d3182622-4b9b-4850-bf9f-108c5610eb40 | 2025-04-01 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| Meloxicam | MELOXICAM | Bryant Ranch Prepack | ed9c8c21-1d08-4afa-9cd2-3fd8b2a83baf | 2025-03-31 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| Meloxicam | MELOXICAM | Bryant Ranch Prepack | 75af3e09-f510-45a4-9f21-50bff7aa5510 | 2025-03-21 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| Meloxicam | MELOXICAM | Bryant Ranch Prepack | 218e71c6-265a-45f4-b660-5c1da5a36bd2 | 2025-03-19 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| Meloxicam | MELOXICAM | Aurobindo Pharma Limited | d5e12448-1ca1-46a4-8de4-e8b94567e5a8 | 2025-03-15 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| MELOXICAM | MELOXICAM | Aphena Pharma Solutions - Tennessee, LLC | 2eaac8b2-d50a-a0bc-e063-6294a90a7cac | 2025-02-21 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| meloxicam | MELOXICAM | A-S Medication Solutions | 29974b41-68b4-42cf-8835-18ae480c2952 | 2025-02-11 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| meloxicam | MELOXICAM | Asclemed USA, Inc. | 4dc34489-cbb6-4e57-a2cc-a274209456f3 | 2025-02-06 | Boxed warning, Warnings, Adverse reactions | MELOXICAM |
| MELOXICAM | MELOXICAM | PD-Rx Pharmaceuticals, Inc. | 25b742d8-5a95-9ec8-e063-6294a90a89ae | 2025-01-03 | 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 |
|---|---|---|---|---|---|
| 70720-115 | QMIIZ ODT | meloxicam | TerSera Therapeutics LLC | NDA | Current |
| 70720-115 | QMIIZ ODT | meloxicam | TerSera Therapeutics LLC | NDA | Current |
| 70720-115 | QMIIZ ODT | meloxicam | TerSera Therapeutics LLC | NDA | Current |
| 70720-175 | QMIIZ ODT | meloxicam | TerSera Therapeutics LLC | NDA | Current |
| 70720-175 | QMIIZ ODT | meloxicam | TerSera Therapeutics LLC | NDA | Current |
| 70720-175 | QMIIZ ODT | meloxicam | TerSera Therapeutics LLC | NDA | Current |