Application 071457
- Type
- ANDA
- Sponsor
- NOVEL LABS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TEMAZEPAM | TEMAZEPAM | CAPSULE;ORAL | 30MG | No | No |
| 002 | TEMAZEPAM | TEMAZEPAM | CAPSULE;ORAL | 7.5MG | No | No |
| 003 | TEMAZEPAM | TEMAZEPAM | CAPSULE;ORAL | 22.5MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A071457-001 | TEMAZEPAM | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 1987-04-21 | |
| A071457-002 | TEMAZEPAM | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2012-06-22 | |
| A071457-003 | TEMAZEPAM | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2012-06-22 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A071457-001 | AB |
| A071457-002 | AB |
| A071457-003 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A071457-001 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 1987-04-21 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A071457-002 | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2012-06-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A071457-003 | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2012-06-22 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A071457-001 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 1987-04-21 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A071457-002 | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2012-06-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A071457-003 | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2012-06-22 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A071457-001 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 1987-04-21 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A071457-002 | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2012-06-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A071457-003 | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2012-06-22 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071457-001 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 1987-04-21 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071457-002 | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2012-06-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071457-003 | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2012-06-22 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A071457-001 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 1987-04-21 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A071457-002 | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2012-06-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A071457-003 | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2012-06-22 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071457-001 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 1987-04-21 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071457-002 | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2012-06-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071457-003 | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2012-06-22 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071457-001 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 1987-04-21 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071457-002 | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2012-06-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071457-003 | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2012-06-22 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071457-001 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 1987-04-21 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071457-002 | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2012-06-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071457-003 | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2012-06-22 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071457-001 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 1987-04-21 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071457-002 | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2012-06-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071457-003 | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2012-06-22 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071457-001 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 1987-04-21 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071457-002 | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2012-06-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071457-003 | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2012-06-22 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071457-001 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 1987-04-21 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071457-002 | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2012-06-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071457-003 | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2012-06-22 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A071457-001 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 1987-04-21 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A071457-002 | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2012-06-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A071457-003 | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2012-06-22 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071457-001 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 1987-04-21 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071457-002 | TEMAZEPAM | 7.5MG | CAPSULE / ORAL | AB | 2012-06-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071457-003 | TEMAZEPAM | 22.5MG | CAPSULE / ORAL | AB | 2012-06-22 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A071457-001 | TEMAZEPAM | 30MG | CAPSULE / ORAL | AB | 1987-04-21 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A071457-001 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A071457-002 | AB | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A071457-003 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A071457-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A071457-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A071457-003 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A071457-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A071457-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A071457-003 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071457-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071457-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071457-003 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A071457-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A071457-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A071457-003 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071457-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071457-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071457-003 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071457-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071457-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071457-003 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071457-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071457-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071457-003 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071457-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071457-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071457-003 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071457-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071457-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071457-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071457-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071457-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071457-003 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A071457-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A071457-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A071457-003 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071457-001 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071457-002 | AB | 1 | 79d66fd596c7… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071457-003 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A071457-001 | AB | 1 | 301d65b070ca… |
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 | Bryant Ranch Prepack | 4ae0c582-8b0f-42f9-9b05-f7e1698c5183 | 2023-11-03 | Boxed warning, Warnings, Adverse reactions | 071457 ANDA071457 63629-8606 |
| temazepam | TEMAZEPAM | Proficient Rx LP | ccf04879-3ad5-4fc3-89f5-879c97887017 | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | 071457 ANDA071457 |
| temazepam | TEMAZEPAM | Proficient Rx LP | 5aaf8c99-cd58-47fc-8bf5-1039a6315ca5 | 2021-01-01 | Warnings, Adverse reactions | 071457 ANDA071457 63187-497 |
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 |
|---|---|---|---|---|---|
| 0440-8474 | temazepam | temazepam | Liberty Pharmaceuticals, Inc. | ANDA | Current |
| 0440-8474 | temazepam | temazepam | Liberty Pharmaceuticals, Inc. | ANDA | Current |
| 0440-8476 | temazepam | temazepam | Liberty Pharmaceuticals, Inc. | ANDA | Current |
| 0440-8476 | temazepam | temazepam | Liberty Pharmaceuticals, Inc. | ANDA | Current |
| 0440-8477 | temazepam | temazepam | Liberty Pharmaceuticals, Inc. | ANDA | Current |
| 0440-8477 | temazepam | temazepam | Liberty Pharmaceuticals, Inc. | ANDA | Current |
| 0904-6436 | Temazepam | Temazepam | Major Pharmaceuticals | ANDA | Current |
| 0904-6436 | Temazepam | Temazepam | Major Pharmaceuticals | ANDA | Current |
| 0904-6436 | Temazepam | Temazepam | Major Pharmaceuticals | ANDA | Current |
| 0904-6436 | Temazepam | Temazepam | Major Pharmaceuticals | ANDA | Current |
| 21695-283 | temazepam | temazepam | Rebel Distributors Corp | ANDA | Current |
| 35356-663 | temazepam | temazepam | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-663 | temazepam | temazepam | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-663 | temazepam | temazepam | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-663 | temazepam | temazepam | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-663 | temazepam | temazepam | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-663 | temazepam | temazepam | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-663 | temazepam | temazepam | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-821 | temazepam | temazepam | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-821 | temazepam | temazepam | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-821 | temazepam | temazepam | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-821 | temazepam | temazepam | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-821 | temazepam | temazepam | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-821 | temazepam | temazepam | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 35356-821 | temazepam | temazepam | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 40032-120 | Temazepam | Temazepam | Novel Laboratories, Inc. | ANDA | Current |
| 40032-122 | Temazepam | Temazepam | Novel Laboratories, Inc. | ANDA | Current |
| 40032-123 | Temazepam | Temazepam | Novel Laboratories, Inc. | ANDA | Current |
| 43353-152 | Temazepam | Temazepam | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-260 | temazepam | temazepam | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 50090-0285 | temazepam | temazepam | A-S Medication Solutions | ANDA | Current |
| 50436-4630 | temazepam | temazepam | Unit Dose Services | ANDA | Current |
| 52959-459 | temazepam | temazepam | H.J. Harkins Company, Inc. | ANDA | Current |
| 53217-205 | temazepam | temazepam | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 55289-660 | temazepam | temazepam | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-660 | temazepam | temazepam | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-660 | temazepam | temazepam | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-660 | temazepam | temazepam | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-660 | temazepam | temazepam | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-660 | temazepam | temazepam | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-660 | temazepam | temazepam | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 55289-660 | temazepam | temazepam | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 61919-264 | TEMAZEPAM | TEMAZEPAM | DirectRX | ANDA | Current |
| 61919-264 | TEMAZEPAM | TEMAZEPAM | DirectRX | ANDA | Current |
| 63187-497 | temazepam | temazepam | Proficient Rx LP | ANDA | Current |
| 63187-497 | temazepam | temazepam | Proficient Rx LP | ANDA | Current |
| 63629-1056 | temazepam | temazepam | Bryant Ranch Prepack | ANDA | Current |
| 63629-1057 | temazepam | temazepam | Bryant Ranch Prepack | ANDA | Current |
| 63629-1057 | temazepam | temazepam | Bryant Ranch Prepack | ANDA | Current |
| 63629-1057 | temazepam | temazepam | Bryant Ranch Prepack | ANDA | Current |
| 63629-1057 | temazepam | temazepam | Bryant Ranch Prepack | ANDA | Current |
| 63629-1621 | temazepam | temazepam | Bryant Ranch Prepack | ANDA | Current |
| 63629-1621 | temazepam | temazepam | Bryant Ranch Prepack | ANDA | Current |
| 63629-1621 | temazepam | temazepam | Bryant Ranch Prepack | ANDA | Current |
| 63629-1621 | temazepam | temazepam | Bryant Ranch Prepack | ANDA | Current |
| 63629-1621 | temazepam | temazepam | Bryant Ranch Prepack | ANDA | Current |
| 63629-8601 | temazepam | temazepam | Bryant Ranch Prepack | ANDA | Current |
| 63629-8601 | temazepam | temazepam | Bryant Ranch Prepack | ANDA | Current |
| 63629-8604 | temazepam | temazepam | Bryant Ranch Prepack | ANDA | Current |
| 63629-8604 | temazepam | temazepam | Bryant Ranch Prepack | ANDA | Current |
| 63629-8605 | temazepam | temazepam | Bryant Ranch Prepack | ANDA | Current |
| 63629-8605 | temazepam | temazepam | Bryant Ranch Prepack | ANDA | Current |
| 63629-8606 | temazepam | temazepam | Bryant Ranch Prepack | ANDA | Current |
| 63629-8606 | temazepam | temazepam | Bryant Ranch Prepack | ANDA | Current |
| 63739-003 | temazepam | temazepam | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-003 | temazepam | temazepam | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-003 | temazepam | temazepam | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-003 | temazepam | temazepam | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-003 | temazepam | temazepam | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-125 | temazepam | temazepam | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-125 | temazepam | temazepam | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-125 | temazepam | temazepam | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 66267-321 | temazepam | temazepam CIV | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 66267-321 | temazepam | temazepam | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 66267-321 | temazepam | temazepam | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 66267-321 | temazepam | temazepam | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 67877-147 | temazepam | temazepam | Ascend Laboratories, LLC | ANDA | Current |
| 67877-147 | temazepam | temazepam | Ascend Laboratories, LLC | ANDA | Current |
| 67877-147 | temazepam | temazepam | Ascend Laboratories, LLC | ANDA | Current |
| 67877-148 | temazepam | temazepam | Ascend Laboratories, LLC | ANDA | Current |