Application 211116
- Type
- ANDA
- Sponsor
- CROSSMEDIKA SA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No |
| 002 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No |
| 003 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | TABLET;ORAL | 150MG | No | No |
| 004 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | TABLET;ORAL | 300MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A211116-001 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2024-05-20 | |
| A211116-002 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2024-05-20 | |
| A211116-003 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2024-05-20 | |
| A211116-004 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2024-05-20 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A211116-001 | AB |
| A211116-002 | AB |
| A211116-003 | AB |
| A211116-004 | AB |
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 | A211116-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2024-05-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A211116-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2024-05-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A211116-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2024-05-20 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A211116-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2024-05-20 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A211116-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2024-05-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211116-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2024-05-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211116-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2024-05-20 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A211116-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2024-05-20 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211116-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2024-05-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211116-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2024-05-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211116-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2024-05-20 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A211116-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2024-05-20 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211116-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2024-05-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211116-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2024-05-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211116-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2024-05-20 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211116-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2024-05-20 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211116-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2024-05-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211116-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2024-05-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211116-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2024-05-20 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A211116-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2024-05-20 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211116-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2024-05-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211116-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2024-05-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211116-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2024-05-20 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211116-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2024-05-20 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211116-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2024-05-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211116-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2024-05-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211116-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2024-05-20 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211116-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2024-05-20 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211116-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2024-05-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211116-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2024-05-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211116-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2024-05-20 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211116-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2024-05-20 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211116-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2024-05-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211116-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2024-05-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211116-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2024-05-20 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211116-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2024-05-20 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211116-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2024-05-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211116-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2024-05-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211116-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2024-05-20 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211116-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2024-05-20 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A211116-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A211116-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A211116-003 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A211116-004 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A211116-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211116-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211116-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A211116-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A211116-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211116-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211116-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A211116-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211116-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211116-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211116-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211116-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A211116-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211116-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211116-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A211116-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211116-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211116-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211116-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211116-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211116-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211116-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211116-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211116-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211116-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211116-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211116-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211116-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211116-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211116-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211116-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211116-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211116-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211116-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211116-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211116-004 | AB | 1 | 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 | Zydus Pharmaceuticals USA Inc. | 704aebf9-2fff-4ef3-8323-9ff0d7f0ffd9 | 2026-01-22 | Boxed warning, Warnings, Adverse reactions | Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | A-S Medication Solutions | 4fcd25d5-e34f-4eea-aeff-aa442651e681 | 2026-01-20 | Boxed warning, Warnings, Adverse reactions | Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | AvKARE | a382ac4d-9ab9-796a-e053-2a95a90a2c26 | 2026-01-15 | Boxed warning, Warnings, Adverse reactions | Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | AvPAK | 9f1c2bf1-5204-7306-e053-2a95a90a9903 | 2026-01-12 | Boxed warning, Warnings, Adverse reactions | Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | A-S Medication Solutions | 353e66cc-98ca-4500-97e7-00f23f122349 | 2026-01-06 | Boxed warning, Warnings, Adverse reactions | Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | f89ad429-0056-e4d6-e053-6294a90a7ab1 | 2026-01-05 | Boxed warning, Warnings, Adverse reactions | Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Northwind Health Company, LLC | f2f2290f-b53c-3b38-e053-2995a90a157d | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Northwind Health Company, LLC | e07d7ee3-776d-1fa3-e053-2a95a90a7019 | 2026-01-01 | Boxed warning, Warnings, Adverse reactions | Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | f98b1e8f-9c66-3e9c-e053-6294a90ab057 | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Accord Healthcare, Inc. | ed3039d8-3d27-4b71-a4b0-812943c9457f | 2025-12-17 | Boxed warning, Warnings, Adverse reactions | Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | Bryant Ranch Prepack | 470a98a2-4e68-4c98-b3c8-e5eba4e55cdc | 2025-12-04 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | Bryant Ranch Prepack | fdd35113-5f51-49c5-a29c-ffdddd28ef38 | 2025-12-04 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | Bryant Ranch Prepack | b57daea8-5a39-41c1-842e-b1d15115e36f | 2025-12-04 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | Bryant Ranch Prepack | 24b5eee4-4210-4b90-a695-11e6a5868988 | 2025-12-04 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | Bryant Ranch Prepack | 7baa8eef-3a5c-43b3-a5fe-0c449aacda2e | 2025-12-04 | Boxed warning, Warnings, Adverse reactions | TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | b716575a-5b96-49c5-bcb2-56b05fbb7920 | 2025-10-29 | Boxed warning, Warnings, Adverse reactions | Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | American Health Packaging | 094ca37b-3ae2-4889-9536-e7e5f20e3105 | 2025-10-14 | Boxed warning, Warnings, Adverse reactions | Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 9b022ae9-dd52-43ae-804b-ddf8e7cfd530 | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | bb3ecde6-72ca-450c-ba88-9cf45c808d90 | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 67d2a90a-3036-409c-aa32-937c55076547 | 2025-10-01 | Boxed warning, Warnings, Adverse reactions | Trazodone Hydrochloride TRAZODONE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.