Application 076309
- Type
- ANDA
- Sponsor
- DR REDDYS LABS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NEFAZODONE HYDROCHLORIDE | NEFAZODONE HYDROCHLORIDE | TABLET;ORAL | 50MG | No | No |
| 002 | NEFAZODONE HYDROCHLORIDE | NEFAZODONE HYDROCHLORIDE | TABLET;ORAL | 100MG | No | No |
| 003 | NEFAZODONE HYDROCHLORIDE | NEFAZODONE HYDROCHLORIDE | TABLET;ORAL | 150MG | No | No |
| 004 | NEFAZODONE HYDROCHLORIDE | NEFAZODONE HYDROCHLORIDE | TABLET;ORAL | 200MG | No | No |
| 005 | NEFAZODONE HYDROCHLORIDE | NEFAZODONE HYDROCHLORIDE | TABLET;ORAL | 250MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076309-001 | NEFAZODONE HYDROCHLORIDE | NEFAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2003-09-16 | ||
| A076309-002 | NEFAZODONE HYDROCHLORIDE | NEFAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2003-09-16 | ||
| A076309-003 | NEFAZODONE HYDROCHLORIDE | NEFAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2003-09-16 | ||
| A076309-004 | NEFAZODONE HYDROCHLORIDE | NEFAZODONE HYDROCHLORIDE | 200MG | TABLET / ORAL | 2003-09-16 | ||
| A076309-005 | NEFAZODONE HYDROCHLORIDE | NEFAZODONE HYDROCHLORIDE | 250MG | TABLET / ORAL | 2003-09-16 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2023-12-20 04:57 UTC | 2023-12 | A076309-001 | NEFAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2003-09-16 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A076309-002 | NEFAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2003-09-16 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A076309-003 | NEFAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2003-09-16 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A076309-004 | NEFAZODONE HYDROCHLORIDE | 200MG | TABLET / ORAL | 2003-09-16 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A076309-005 | NEFAZODONE HYDROCHLORIDE | 250MG | TABLET / ORAL | 2003-09-16 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076309-001 | NEFAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2003-09-16 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076309-002 | NEFAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2003-09-16 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076309-003 | NEFAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2003-09-16 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076309-004 | NEFAZODONE HYDROCHLORIDE | 200MG | TABLET / ORAL | 2003-09-16 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076309-005 | NEFAZODONE HYDROCHLORIDE | 250MG | TABLET / ORAL | 2003-09-16 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076309-001 | NEFAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2003-09-16 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076309-002 | NEFAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2003-09-16 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076309-003 | NEFAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2003-09-16 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076309-004 | NEFAZODONE HYDROCHLORIDE | 200MG | TABLET / ORAL | 2003-09-16 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076309-005 | NEFAZODONE HYDROCHLORIDE | 250MG | TABLET / ORAL | 2003-09-16 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076309-001 | NEFAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2003-09-16 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076309-002 | NEFAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2003-09-16 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076309-003 | NEFAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2003-09-16 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076309-004 | NEFAZODONE HYDROCHLORIDE | 200MG | TABLET / ORAL | 2003-09-16 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076309-005 | NEFAZODONE HYDROCHLORIDE | 250MG | TABLET / ORAL | 2003-09-16 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076309-001 | NEFAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2003-09-16 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076309-002 | NEFAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2003-09-16 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076309-003 | NEFAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2003-09-16 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076309-004 | NEFAZODONE HYDROCHLORIDE | 200MG | TABLET / ORAL | 2003-09-16 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076309-005 | NEFAZODONE HYDROCHLORIDE | 250MG | TABLET / ORAL | 2003-09-16 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A076309-001 | NEFAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2003-09-16 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A076309-002 | NEFAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2003-09-16 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A076309-003 | NEFAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2003-09-16 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A076309-004 | NEFAZODONE HYDROCHLORIDE | 200MG | TABLET / ORAL | 2003-09-16 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A076309-005 | NEFAZODONE HYDROCHLORIDE | 250MG | TABLET / ORAL | 2003-09-16 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A076309-001 | NEFAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2003-09-16 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A076309-002 | NEFAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2003-09-16 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A076309-003 | NEFAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2003-09-16 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A076309-004 | NEFAZODONE HYDROCHLORIDE | 200MG | TABLET / ORAL | 2003-09-16 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A076309-005 | NEFAZODONE HYDROCHLORIDE | 250MG | TABLET / ORAL | 2003-09-16 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076309-001 | NEFAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2003-09-16 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076309-002 | NEFAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2003-09-16 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076309-003 | NEFAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2003-09-16 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076309-004 | NEFAZODONE HYDROCHLORIDE | 200MG | TABLET / ORAL | 2003-09-16 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076309-005 | NEFAZODONE HYDROCHLORIDE | 250MG | TABLET / ORAL | 2003-09-16 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| Nefazodone Hydrochloride | NEFAZODONE HYDROCHLORIDE | Bryant Ranch Prepack | 0bd4c34a-4f43-4c84-8b98-1d074cba97d5 | 2025-09-04 | Boxed warning, Warnings, Adverse reactions | Nefazodone Hydrochloride NEFAZODONE HYDROCHLORIDE |
| Nefazodone Hydrochloride | NEFAZODONE HYDROCHLORIDE | Teva Pharmaceuticals USA, Inc. | 51ff7db5-aaf9-4c3c-86e6-958ebf16b60f | 2025-07-31 | Boxed warning, Warnings, Adverse reactions | Nefazodone Hydrochloride NEFAZODONE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 23817 | ORIG | 2007-05-09 |