Application 076037
- Type
- ANDA
- Sponsor
- TEVA
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 | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076037-001 | NEFAZODONE HYDROCHLORIDE | NEFAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2003-09-16 | ||
| A076037-002 | NEFAZODONE HYDROCHLORIDE | NEFAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2003-09-16 | ||
| A076037-003 | NEFAZODONE HYDROCHLORIDE | NEFAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2003-09-16 | ||
| A076037-004 | NEFAZODONE HYDROCHLORIDE | NEFAZODONE HYDROCHLORIDE | 200MG | TABLET / ORAL | 2003-09-16 | ||
| A076037-005 | NEFAZODONE HYDROCHLORIDE | NEFAZODONE HYDROCHLORIDE | 250MG | TABLET / ORAL | RS | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-05-31 18:47 UTC | 2024-05 | A076037-001 | NEFAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2003-09-16 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076037-002 | NEFAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2003-09-16 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076037-003 | NEFAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2003-09-16 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076037-004 | NEFAZODONE HYDROCHLORIDE | 200MG | TABLET / ORAL | 2003-09-16 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076037-005 | NEFAZODONE HYDROCHLORIDE | 250MG | TABLET / ORAL | RS | 2003-09-16 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076037-001 | NEFAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2003-09-16 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076037-002 | NEFAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2003-09-16 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076037-003 | NEFAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2003-09-16 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076037-004 | NEFAZODONE HYDROCHLORIDE | 200MG | TABLET / ORAL | 2003-09-16 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076037-005 | NEFAZODONE HYDROCHLORIDE | 250MG | TABLET / ORAL | RS | 2003-09-16 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A076037-001 | NEFAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2003-09-16 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076037-002 | NEFAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2003-09-16 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076037-003 | NEFAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2003-09-16 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076037-004 | NEFAZODONE HYDROCHLORIDE | 200MG | TABLET / ORAL | 2003-09-16 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076037-005 | NEFAZODONE HYDROCHLORIDE | 250MG | TABLET / ORAL | RS | 2003-09-16 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A076037-001 | NEFAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2003-09-16 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076037-002 | NEFAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2003-09-16 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076037-003 | NEFAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2003-09-16 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076037-004 | NEFAZODONE HYDROCHLORIDE | 200MG | TABLET / ORAL | 2003-09-16 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076037-005 | NEFAZODONE HYDROCHLORIDE | 250MG | TABLET / ORAL | RS | 2003-09-16 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A076037-001 | NEFAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2003-09-16 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076037-002 | NEFAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2003-09-16 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076037-003 | NEFAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2003-09-16 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076037-004 | NEFAZODONE HYDROCHLORIDE | 200MG | TABLET / ORAL | 2003-09-16 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076037-005 | NEFAZODONE HYDROCHLORIDE | 250MG | TABLET / ORAL | RS | 2003-09-16 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A076037-001 | NEFAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2003-09-16 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076037-002 | NEFAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2003-09-16 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076037-003 | NEFAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2003-09-16 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076037-004 | NEFAZODONE HYDROCHLORIDE | 200MG | TABLET / ORAL | 2003-09-16 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A076037-005 | NEFAZODONE HYDROCHLORIDE | 250MG | TABLET / ORAL | RS | 2003-09-16 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A076037-001 | NEFAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2003-09-16 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076037-002 | NEFAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2003-09-16 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076037-003 | NEFAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2003-09-16 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076037-004 | NEFAZODONE HYDROCHLORIDE | 200MG | TABLET / ORAL | 2003-09-16 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076037-005 | NEFAZODONE HYDROCHLORIDE | 250MG | TABLET / ORAL | RS | 2003-09-16 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076037-001 | NEFAZODONE HYDROCHLORIDE | 50MG | TABLET / ORAL | 2003-09-16 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076037-002 | NEFAZODONE HYDROCHLORIDE | 100MG | TABLET / ORAL | 2003-09-16 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076037-003 | NEFAZODONE HYDROCHLORIDE | 150MG | TABLET / ORAL | 2003-09-16 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076037-004 | NEFAZODONE HYDROCHLORIDE | 200MG | TABLET / ORAL | 2003-09-16 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076037-005 | NEFAZODONE HYDROCHLORIDE | 250MG | TABLET / ORAL | RS | 2003-09-16 | 87673890dc5c… |
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 | 076037 ANDA076037 63629-7046 |
| Nefazodone Hydrochloride | NEFAZODONE HYDROCHLORIDE | Teva Pharmaceuticals USA, Inc. | 51ff7db5-aaf9-4c3c-86e6-958ebf16b60f | 2025-07-31 | Boxed warning, Warnings, Adverse reactions | 076037 ANDA076037 0093-7178 0093-1024 0093-1026 0093-1025 0093-7113 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0093-1024 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-1024 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-1024 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-1024 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-1024 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-1025 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-1025 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-1025 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-1025 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-1025 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-1026 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-1026 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-1026 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-1026 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-1026 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7113 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7113 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7113 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7113 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7113 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7178 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7178 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7178 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7178 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-7178 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 21695-174 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Rebel Distributors Corp | ANDA | Current |
| 21695-175 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Rebel Distributors Corp | ANDA | Current |
| 21695-176 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Rebel Distributors Corp | ANDA | Current |
| 21695-177 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Rebel Distributors Corp | ANDA | Current |
| 63629-7046 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-7046 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-7046 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-7214 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-7214 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-7310 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-7310 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 68788-7217 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7217 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7217 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7242 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7242 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7242 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7246 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7246 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7246 | Nefazodone Hydrochloride | Nefazodone Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |