Application 204852
- Type
- ANDA
- Sponsor
- AUROLIFE PHARMA LLC
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 |
|---|---|---|---|---|---|---|---|
| A204852-001 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2020-02-05 | |
| A204852-002 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2020-02-05 | |
| A204852-003 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2020-02-05 | |
| A204852-004 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2020-02-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A204852-001 | AB |
| A204852-002 | AB |
| A204852-003 | AB |
| A204852-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A204852-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2020-02-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204852-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2020-02-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204852-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2020-02-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A204852-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2020-02-05 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204852-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2020-02-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204852-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2020-02-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204852-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2020-02-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204852-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2020-02-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204852-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2020-02-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204852-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2020-02-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204852-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2020-02-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204852-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2020-02-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204852-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2020-02-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204852-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2020-02-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204852-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2020-02-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204852-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2020-02-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204852-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2020-02-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204852-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2020-02-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204852-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2020-02-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204852-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2020-02-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204852-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2020-02-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204852-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2020-02-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204852-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2020-02-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204852-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2020-02-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204852-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2020-02-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204852-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2020-02-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204852-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2020-02-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204852-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2020-02-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204852-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2020-02-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204852-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2020-02-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204852-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2020-02-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204852-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2020-02-05 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204852-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2020-02-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204852-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2020-02-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204852-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2020-02-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204852-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2020-02-05 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204852-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2020-02-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204852-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2020-02-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204852-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2020-02-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204852-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2020-02-05 | d8e5a09893c0… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A204852-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204852-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204852-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A204852-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A204852-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204852-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204852-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204852-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204852-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204852-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204852-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204852-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A204852-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204852-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204852-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204852-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204852-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204852-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204852-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204852-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204852-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204852-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204852-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204852-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204852-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204852-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204852-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204852-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204852-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204852-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204852-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204852-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204852-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204852-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204852-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204852-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204852-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204852-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204852-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204852-004 | AB | 1 | d8e5a09893c0… |
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. | fec78f5d-2567-44d3-9f04-1a6913357019 | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | 204852 ANDA204852 |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | Bryant Ranch Prepack | 34986e81-da05-46c1-8dd6-1dd7a8d1a44f | 2026-03-30 | Boxed warning, Warnings, Adverse reactions | 204852 ANDA204852 |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | Bryant Ranch Prepack | dfd2698d-b7a3-49e0-aa2f-1af0ca894b35 | 2026-03-13 | Boxed warning, Warnings, Adverse reactions | 204852 ANDA204852 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | f89ad429-0056-e4d6-e053-6294a90a7ab1 | 2026-01-05 | Boxed warning, Warnings, Adverse reactions | 204852 ANDA204852 |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | Bryant Ranch Prepack | 470a98a2-4e68-4c98-b3c8-e5eba4e55cdc | 2025-12-04 | Boxed warning, Warnings, Adverse reactions | 204852 ANDA204852 |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | Bryant Ranch Prepack | fdd35113-5f51-49c5-a29c-ffdddd28ef38 | 2025-12-04 | Boxed warning, Warnings, Adverse reactions | 204852 ANDA204852 |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | Bryant Ranch Prepack | b57daea8-5a39-41c1-842e-b1d15115e36f | 2025-12-04 | Boxed warning, Warnings, Adverse reactions | 204852 ANDA204852 |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | Bryant Ranch Prepack | 24b5eee4-4210-4b90-a695-11e6a5868988 | 2025-12-04 | Boxed warning, Warnings, Adverse reactions | 204852 ANDA204852 |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | Bryant Ranch Prepack | 7baa8eef-3a5c-43b3-a5fe-0c449aacda2e | 2025-12-04 | Boxed warning, Warnings, Adverse reactions | 204852 ANDA204852 |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | Bryant Ranch Prepack | 4370fe5c-1c40-499b-abb5-bca0a39834c6 | 2025-09-19 | Boxed warning, Warnings, Adverse reactions | 204852 ANDA204852 |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | Bryant Ranch Prepack | a343910a-bf4c-4a41-b0ee-0e90e8355815 | 2025-09-19 | Boxed warning, Warnings, Adverse reactions | 204852 ANDA204852 |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | Bryant Ranch Prepack | 1514b3b0-7742-4247-b9fd-ea14849d3fdd | 2025-09-19 | Boxed warning, Warnings, Adverse reactions | 204852 ANDA204852 |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | REMEDYREPACK INC. | b0a79ee7-3140-48cb-b734-244a4420e32c | 2025-08-14 | Boxed warning, Warnings, Adverse reactions | 204852 ANDA204852 |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | Aurolife Pharma LLC | 295e92a9-bcb0-4d53-ba62-e30020e9834b | 2025-04-02 | Boxed warning, Warnings, Adverse reactions | 204852 ANDA204852 13107-079 13107-080 13107-082 13107-081 |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 30ca6faa-316d-5754-e063-6394a90a7eff | 2025-03-20 | Boxed warning, Warnings, Adverse reactions | 204852 ANDA204852 |
| Trazodone Hydrochloride | TRAZODONE HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | f8fc1f03-cd9d-9fa9-e053-6294a90a8665 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | 204852 ANDA204852 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 13107-079 | Trazodone Hydrochloride | Trazodone Hydrochloride | Aurolife Pharma, LLC | ANDA | Current |
| 13107-080 | Trazodone Hydrochloride | Trazodone Hydrochloride | Aurolife Pharma, LLC | ANDA | Current |
| 13107-081 | Trazodone Hydrochloride | Trazodone Hydrochloride | Aurolife Pharma, LLC | ANDA | Current |
| 13107-082 | Trazodone Hydrochloride | Trazodone Hydrochloride | Aurolife Pharma, LLC | ANDA | Current |