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| TRAZODONE HYDROCHLORIDE | TABLET;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| TRAZODONE HYDROCHLORIDE | TABLET;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| TRAZODONE HYDROCHLORIDE | TABLET;ORAL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| TRAZODONE HYDROCHLORIDE | TABLET;ORAL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| DESYREL | TRAZODONE HYDROCHLORIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||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| DESYREL | TRAZODONE HYDROCHLORIDE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||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| DESYREL | TRAZODONE HYDROCHLORIDE | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-03-25 | |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| DESYREL | TRAZODONE HYDROCHLORIDE | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-11-07 |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 | Coupler LLC | 2c7dca0c-8313-7d85-e063-6294a90aca61 | 2025-01-27 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | f8fc1f03-cd9d-9fa9-e053-6294a90a8665 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 29ac7183-e574-506e-e063-6394a90a77c9 | 2024-12-19 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | A-S Medication Solutions | be0dc037-d30a-4f07-ab7c-1695637b3740 | 2024-11-08 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Bryant Ranch Prepack | a71063f9-cdc6-46bc-9eb4-626f288e46d9 | 2024-10-31 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Bryant Ranch Prepack | 9df17765-5d41-4e26-98de-850658114534 | 2024-08-08 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 85bb3f78-5cf2-1319-e053-2991aa0ade75 | 2024-06-14 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 6adb446d-cd2f-3d6b-e053-2991aa0a2114 | 2024-06-10 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Proficient Rx LP | 88ac1a9d-8483-4b29-9fe6-2e60e51f3005 | 2024-05-01 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Medsource Pharmaceuticals | 138fef7b-db83-88c4-e063-6394a90ab0ac | 2024-03-13 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Medsource Pharmaceuticals | 12f1737b-c021-d0f2-e063-6294a90a6f29 | 2024-03-05 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Asclemed USA, Inc. | 04a676ee-358e-484d-9de4-a9a88d908ba8 | 2024-02-26 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | A-S Medication Solutions | 3df90104-ef2c-4a82-b007-9843c43969ae | 2023-12-16 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | A-S Medication Solutions | ac678c51-b1d3-4d6b-9599-7ef565b469d2 | 2023-10-16 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Proficient Rx LP | 3c8c3d2b-9108-40fa-90d9-6ed545cf6549 | 2023-06-01 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Proficient Rx LP | 203881a3-37d0-41dd-86c5-1e53fb784326 | 2023-05-01 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Proficient Rx LP | a90caa68-b28e-425f-b77c-7b566ac17dc2 | 2022-08-01 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Proficient Rx LP | f6c3fb84-5b68-4675-a853-fe49bfbf3f9f | 2022-06-01 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Proficient Rx LP | 2a1d0989-6ed5-4a2f-bd03-73d61eb40232 | 2022-06-01 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 5d22a06c-9cb8-4b49-8d67-769d181ad70c | 2021-03-10 | 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 |