Application 217875
- Type
- ANDA
- Sponsor
- ALKEM LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TEMAZEPAM | TEMAZEPAM | CAPSULE;ORAL | 7.5MG | No | No |
| 002 | TEMAZEPAM | TEMAZEPAM | CAPSULE;ORAL | 15MG | No | No |
| 003 | TEMAZEPAM | TEMAZEPAM | CAPSULE;ORAL | 22.5MG | No | No |
| 004 | TEMAZEPAM | TEMAZEPAM | CAPSULE;ORAL | 30MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A217875-001 | TEMAZEPAM | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2023-08-24 | |
| A217875-002 | TEMAZEPAM | TEMAZEPAM | 15MG | CAPSULE / ORAL | AB | 2023-08-24 | |
| A217875-003 | TEMAZEPAM | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2023-08-24 | |
| A217875-004 | TEMAZEPAM | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 2023-08-24 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A217875-001 | AB |
| A217875-002 | AB |
| A217875-003 | AB |
| A217875-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A217875-001 | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2023-08-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217875-002 | TEMAZEPAM | 15MG | CAPSULE / ORAL | AB | 2023-08-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217875-003 | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2023-08-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A217875-004 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 2023-08-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217875-001 | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2023-08-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217875-002 | TEMAZEPAM | 15MG | CAPSULE / ORAL | AB | 2023-08-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217875-003 | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2023-08-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217875-004 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 2023-08-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217875-001 | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2023-08-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217875-002 | TEMAZEPAM | 15MG | CAPSULE / ORAL | AB | 2023-08-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217875-003 | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2023-08-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A217875-004 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 2023-08-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217875-001 | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2023-08-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217875-002 | TEMAZEPAM | 15MG | CAPSULE / ORAL | AB | 2023-08-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217875-003 | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2023-08-24 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217875-004 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 2023-08-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217875-001 | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2023-08-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217875-002 | TEMAZEPAM | 15MG | CAPSULE / ORAL | AB | 2023-08-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217875-003 | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2023-08-24 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217875-004 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 2023-08-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217875-001 | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2023-08-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217875-002 | TEMAZEPAM | 15MG | CAPSULE / ORAL | AB | 2023-08-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217875-003 | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2023-08-24 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217875-004 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 2023-08-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217875-001 | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2023-08-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217875-002 | TEMAZEPAM | 15MG | CAPSULE / ORAL | AB | 2023-08-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217875-003 | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2023-08-24 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217875-004 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 2023-08-24 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217875-001 | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2023-08-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217875-002 | TEMAZEPAM | 15MG | CAPSULE / ORAL | AB | 2023-08-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217875-003 | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2023-08-24 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217875-004 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 2023-08-24 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217875-001 | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2023-08-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217875-002 | TEMAZEPAM | 15MG | CAPSULE / ORAL | AB | 2023-08-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217875-003 | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2023-08-24 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217875-004 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 2023-08-24 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A217875-001 | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2023-08-24 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A217875-002 | TEMAZEPAM | 15MG | CAPSULE / ORAL | AB | 2023-08-24 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A217875-003 | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2023-08-24 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A217875-004 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 2023-08-24 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A217875-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217875-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217875-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A217875-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217875-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217875-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217875-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A217875-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A217875-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217875-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217875-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A217875-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217875-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217875-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217875-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A217875-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217875-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217875-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217875-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A217875-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217875-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217875-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217875-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A217875-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217875-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217875-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217875-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A217875-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217875-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217875-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217875-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A217875-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217875-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217875-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217875-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A217875-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A217875-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A217875-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A217875-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A217875-004 | AB | 1 | d06236e962d9… |
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 |
|---|---|---|---|---|---|---|
| temazepam | TEMAZEPAM | Ascend Laboratories, LLC | 8f54731f-c5b7-492c-acb0-444c5fbb7029 | 2026-08-05 | Boxed warning, Warnings, Adverse reactions | temazepam TEMAZEPAM |
| Temazepam | TEMAZEPAM | REMEDYREPACK INC. | 85919240-0bac-4ed9-97aa-f1aa29be7ffa | 2026-07-24 | Boxed warning, Warnings, Adverse reactions | Temazepam TEMAZEPAM |
| temazepam | TEMAZEPAM | REMEDYREPACK INC. | 65857a9b-a225-4887-b0dc-58ab6d60f9d0 | 2026-06-30 | Boxed warning, Warnings, Adverse reactions | temazepam TEMAZEPAM |
| RESTORIL | TEMAZEPAM | SpecGx LLC | bc56f7fd-1aaf-48ff-8aa7-d467e59e1015 | 2026-06-09 | Boxed warning, Warnings, Adverse reactions | TEMAZEPAM |
| TEMAZEPAM | TEMAZEPAM | SpecGx LLC | c9bc61b4-a579-4003-98da-b6f6e381c150 | 2026-06-04 | Boxed warning, Warnings, Adverse reactions | TEMAZEPAM TEMAZEPAM |
| Temazepam | TEMAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 4a2ab77d-8b80-7eb1-e063-6394a90a1469 | 2026-02-09 | Boxed warning, Warnings, Adverse reactions | Temazepam TEMAZEPAM |
| temazepam | TEMAZEPAM | Preferred Pharmaceuticals Inc. | 7e3fd8fe-fb8a-4577-b540-0e3fefe63627 | 2026-01-14 | Boxed warning, Warnings, Adverse reactions | temazepam TEMAZEPAM |
| Temazepam | TEMAZEPAM | American Health Packaging | a3f06243-fa03-4cbd-951a-144ec43dcdfd | 2025-11-13 | Boxed warning, Warnings, Adverse reactions | Temazepam TEMAZEPAM |
| temazepam | TEMAZEPAM | Bryant Ranch Prepack | 4fe8192a-0f65-4958-8b6d-e87b9fae9eb5 | 2025-11-06 | Boxed warning, Warnings, Adverse reactions | temazepam TEMAZEPAM |
| temazepam | TEMAZEPAM | Bryant Ranch Prepack | bbb6e233-dc6b-43a7-8203-d91421d89921 | 2025-11-06 | Boxed warning, Warnings, Adverse reactions | temazepam TEMAZEPAM |
| temazepam | TEMAZEPAM | Bryant Ranch Prepack | a1f0ed55-9401-4afe-ba98-1ca115ba86b5 | 2025-11-06 | Boxed warning, Warnings, Adverse reactions | temazepam TEMAZEPAM |
| temazepam | TEMAZEPAM | A-S Medication Solutions | 19b2711e-587a-47d2-ab62-d564e7b87195 | 2025-10-27 | Boxed warning, Warnings, Adverse reactions | temazepam TEMAZEPAM |
| temazepam | TEMAZEPAM | PD-Rx Pharmaceuticals, Inc. | 45ef5e9c-f381-48d3-895d-e1d29be856ac | 2025-10-20 | Boxed warning, Warnings, Adverse reactions | temazepam TEMAZEPAM |
| temazepam | TEMAZEPAM | PD-Rx Pharmaceuticals, Inc. | 62379cd5-a314-43eb-a1ee-33997623bfa3 | 2025-10-20 | Boxed warning, Warnings, Adverse reactions | temazepam TEMAZEPAM |
| TEMAZEPAM | TEMAZEPAM | PD-Rx Pharmaceuticals, Inc. | 97afda58-4daf-4192-bd87-3ccbb000ee52 | 2025-10-14 | Boxed warning, Warnings, Adverse reactions | TEMAZEPAM TEMAZEPAM |
| temazepam | TEMAZEPAM | Bryant Ranch Prepack | dadc2f66-7fa5-4be4-a9d0-d96e5836f550 | 2025-10-09 | Boxed warning, Warnings, Adverse reactions | temazepam TEMAZEPAM |
| temazepam | TEMAZEPAM | Asclemed USA, Inc. | 254a0273-c0f3-4d2d-b18e-4ab51ba4bc50 | 2025-10-08 | Boxed warning, Warnings, Adverse reactions | temazepam TEMAZEPAM |
| Temazepam | TEMAZEPAM | Preferred Pharmaceuticals Inc. | cbe5bd6a-f36a-4557-82d8-ef4e49d310e9 | 2025-09-29 | Boxed warning, Warnings, Adverse reactions | Temazepam TEMAZEPAM |
| temazepam | TEMAZEPAM | Preferred Pharmaceuticals Inc. | 42b81d6f-8171-4cd0-ab79-f031a8254d65 | 2025-09-29 | Boxed warning, Warnings, Adverse reactions | temazepam TEMAZEPAM |
| Temazepam | TEMAZEPAM | Bryant Ranch Prepack | 38afa73c-7c87-440d-bece-f268e8e4a44c | 2025-03-28 | Boxed warning, Warnings, Adverse reactions | Temazepam TEMAZEPAM |