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| TRAZODONE HYDROCHLORIDE | TABLET;ORAL | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| TRAZODONE HYDROCHLORIDE | TABLET;ORAL | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| TRAZODONE HYDROCHLORIDE | TABLET;ORAL | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| TRAZODONE HYDROCHLORIDE | TABLET;ORAL | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| DESYREL | TRAZODONE HYDROCHLORIDE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||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| DESYREL | TRAZODONE HYDROCHLORIDE | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD, Approved before 1982 | ||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| DESYREL | TRAZODONE HYDROCHLORIDE | 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1985-03-25 | |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| DESYREL | TRAZODONE HYDROCHLORIDE | 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1988-11-07 |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 | REMEDYREPACK INC. | fa7afa93-b98c-4dc7-bbb8-ab6a058427b9 | 2026-09-08 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | TRUPHARMA LLC | a57da4f8-151d-4a74-8710-6158d1da3852 | 2026-09-03 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | REMEDYREPACK INC. | 3b2e61b0-414c-48ae-9e13-06470c302c67 | 2026-08-27 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 596c3f00-1504-eaed-e063-6294a90a08bb | 2026-08-19 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | American Health Packaging | f715085a-be56-497e-ad92-9fec3aba70b5 | 2026-08-14 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | REMEDYREPACK INC. | 1f74b23d-f2eb-4c18-a583-d608b7713694 | 2026-08-10 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | REMEDYREPACK INC. | dc1f347e-1acb-4c06-b36e-f15fecb7ac93 | 2026-08-07 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | REMEDYREPACK INC. | acd077db-e2b8-4d29-94c0-128439050c66 | 2026-08-07 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | NuCare Pharmceuticals,Inc. | 81a5b557-06f6-2470-e053-2991aa0a64fd | 2026-08-06 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | REMEDYREPACK INC. | a31d59ed-5949-4f85-8b73-3bfd7f72d5b8 | 2026-08-05 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | REMEDYREPACK INC. | 7bba99e5-4096-4fcb-8591-dc4a9bfe975e | 2026-07-31 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Golden State Medical Supply, Inc. | 51012256-b249-ccbb-e063-6394a90af4fa | 2026-07-30 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | REMEDYREPACK INC. | 2863317d-657b-4dc6-81fb-b7158ea03498 | 2026-07-20 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | A-S Medication Solutions | 007f38e0-653b-43e4-a1c1-b59997b2762a | 2026-07-14 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Bryant Ranch Prepack | 68bcae4b-f4c3-4d28-af76-d182b707fc73 | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Oxford Pharmaceuticals, LLC | 283c8236-9776-44cb-b7b2-1024689de736 | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Granules Pharmaceuticals Inc. | 5bc5f266-6c0e-4b9a-b6e0-ea694928b948 | 2026-07-09 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Unit Dose Solutions, Inc. | 562fa890-0a39-9361-e063-6294a90a1bb5 | 2026-07-09 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Unit Dose Solutions, Inc. | 562fdfb9-c060-63bc-e063-6294a90ad840 | 2026-07-09 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 04c287ca-5efa-469d-ab39-ff16d9b1e0b3 | 2026-07-07 | 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 |