Application 217740
- Type
- ANDA
- Sponsor
- GRAVITI PHARMS
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 |
|---|---|---|---|---|---|---|---|
| A217740-001 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2024-08-27 | |
| A217740-002 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2024-08-27 | |
| A217740-003 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2024-08-27 | |
| A217740-004 | TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2024-08-27 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A217740-001 | AB |
| A217740-002 | AB |
| A217740-003 | AB |
| A217740-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A217740-001 | TRAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | AB | 2024-08-27 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A217740-002 | TRAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | AB | 2024-08-27 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A217740-003 | TRAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | AB | 2024-08-27 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A217740-004 | TRAZODONE HYDROCHLORIDE | 300MG | TABLET / ORAL | AB | 2024-08-27 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A217740-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A217740-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A217740-003 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A217740-004 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | REMEDYREPACK INC. | 1ec27d5d-1a88-428e-8de2-7418a3535a18 | 2026-07-03 | Boxed warning, Warnings, Adverse reactions | 217740 ANDA217740 |
| TRAZODONE HYDROCHLORIDE | TRAZODONE HYDROCHLORIDE | Rising Pharma Holdings, Inc. | ef26e4f0-f31f-4efa-9938-28c886cf3d1d | 2025-04-02 | Boxed warning, Warnings, Adverse reactions | 217740 ANDA217740 |