Application 018207
- Type
- NDA
- Sponsor
- PRAGMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DESYREL | TRAZODONE HYDROCHLORIDE | TABLET;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | DESYREL | TRAZODONE HYDROCHLORIDE | TABLET;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 003 | DESYREL | TRAZODONE HYDROCHLORIDE | TABLET;ORAL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | DESYREL | TRAZODONE HYDROCHLORIDE | TABLET;ORAL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018207-001 | DESYREL | TRAZODONE HYDROCHLORIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N018207-002 | DESYREL | TRAZODONE HYDROCHLORIDE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||
| N018207-003 | DESYREL | TRAZODONE HYDROCHLORIDE | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-03-25 | |
| N018207-004 | DESYREL | TRAZODONE HYDROCHLORIDE | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-11-07 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N018207-001 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | |
| N018207-002 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | |
| N018207-003 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | |
| N018207-004 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 |
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 | N018207-001 | DESYREL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N018207-002 | DESYREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N018207-003 | DESYREL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-03-25 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N018207-004 | DESYREL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-11-07 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N018207-001 | DESYREL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N018207-002 | DESYREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N018207-003 | DESYREL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-03-25 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N018207-004 | DESYREL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-11-07 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018207-001 | DESYREL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N018207-002 | DESYREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N018207-003 | DESYREL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-03-25 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018207-004 | DESYREL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-11-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018207-001 | DESYREL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018207-002 | DESYREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018207-003 | DESYREL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-03-25 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018207-004 | DESYREL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-11-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018207-001 | DESYREL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N018207-002 | DESYREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N018207-003 | DESYREL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-03-25 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018207-004 | DESYREL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-11-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018207-001 | DESYREL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018207-002 | DESYREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018207-003 | DESYREL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-03-25 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018207-004 | DESYREL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-11-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018207-001 | DESYREL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018207-002 | DESYREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018207-003 | DESYREL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-03-25 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018207-004 | DESYREL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-11-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018207-001 | DESYREL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018207-002 | DESYREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018207-003 | DESYREL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-03-25 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018207-004 | DESYREL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-11-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018207-001 | DESYREL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018207-002 | DESYREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018207-003 | DESYREL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-03-25 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018207-004 | DESYREL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-11-07 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018207-001 | DESYREL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018207-002 | DESYREL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018207-003 | DESYREL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-03-25 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018207-004 | DESYREL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-11-07 | 5bbf6a4d5a75… |
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 | N018207-001 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N018207-002 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N018207-003 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N018207-004 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N018207-001 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N018207-002 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N018207-003 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N018207-004 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018207-001 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018207-002 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018207-003 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N018207-004 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018207-001 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018207-002 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018207-003 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018207-004 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018207-001 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018207-002 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018207-003 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N018207-004 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018207-001 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018207-002 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018207-003 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018207-004 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018207-001 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018207-002 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018207-003 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018207-004 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018207-001 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018207-002 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018207-003 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018207-004 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018207-001 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018207-002 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018207-003 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018207-004 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018207-001 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018207-002 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018207-003 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018207-004 | 8133893 | 2029-03-13 | Drug substance, Drug product | 2015-07-20 | 5bbf6a4d5a75… |
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 |
|---|---|---|---|---|---|---|
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 9962589c-ee1f-4d5e-bd49-b7807bb60ace | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | Bryant Ranch Prepack | 4370fe5c-1c40-499b-abb5-bca0a39834c6 | 2025-09-19 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | Bryant Ranch Prepack | a343910a-bf4c-4a41-b0ee-0e90e8355815 | 2025-09-19 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | Bryant Ranch Prepack | 1514b3b0-7742-4247-b9fd-ea14849d3fdd | 2025-09-19 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | d42fd0c8-3673-4f18-a6c0-cd276bbf9fef | 2025-09-16 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | f7e6a78e-7ac3-35b9-e053-6294a90aabd0 | 2025-08-20 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 5ab590d8-225f-43f4-bb68-1f2c86f9a886 | 2025-07-24 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Major Pharmaceuticals | 8eb85c26-a6cb-4a10-a990-ccc0b20aff08 | 2025-07-21 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Teva Pharmaceuticals USA, Inc. | 4006d439-e2de-4590-82e9-fc9d56e3ec1b | 2025-07-09 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Cardinal Health 107, LLC | 9265f4f6-df24-4495-9dbf-e3fcfa4c864d | 2025-07-02 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Bryant Ranch Prepack | 42ecd35c-4300-4cd3-942a-f3efb872fa99 | 2025-06-12 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Bryant Ranch Prepack | adc7427e-3553-4805-b063-eeda84049029 | 2025-06-03 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Bryant Ranch Prepack | 65ef34fb-8fe4-4e9d-9068-98702515ffeb | 2025-04-23 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | f291b905-a739-5e43-e053-2995a90ac40c | 2025-04-08 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | Rising Pharma Holdings, Inc. | ef26e4f0-f31f-4efa-9938-28c886cf3d1d | 2025-04-02 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | Aurolife Pharma LLC | 295e92a9-bcb0-4d53-ba62-e30020e9834b | 2025-04-02 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Coupler LLC | 31356804-951b-68c7-e063-6294a90a6410 | 2025-03-25 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 30ca6faa-316d-5754-e063-6394a90a7eff | 2025-03-20 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | fc9b90d1-7da5-efc1-e053-6294a90a0223 | 2025-02-04 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 2d3f1d0b-3686-f4d7-e063-6394a90a1a76 | 2025-02-03 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85061 | SUPPL | 2026-02-18 |
| 82660 | SUPPL | 2025-06-25 |
| 56052 | SUPPL | 2018-10-22 |
| 56017 | SUPPL | 2018-10-19 |
| 56016 | SUPPL | 2018-10-19 |
| 48907 | SUPPL | 2017-07-05 |
| 48893 | SUPPL | 2017-07-03 |
| 48892 | SUPPL | 2017-07-03 |
| 14946 | SUPPL | 2014-07-21 |
| 23541 | ORIG | 2007-05-09 |
| 33456 | SUPPL | 2005-01-13 |
| 874 | SUPPL | 2005-01-13 |
| 873 | SUPPL | 2004-03-19 |