Application 019287
- Type
- NDA
- Sponsor
- PHARMACIA AND UPJOHN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DIZAC | DIAZEPAM | INJECTABLE;INJECTION | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019287-001 | DIZAC | DIAZEPAM | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1993-06-18 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1993-06-18 | c2088c7a36db… | ||
| 2026-09-14 22:38:34 | 2026-08 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1993-06-18 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1993-06-18 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1993-06-18 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1993-06-18 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1993-06-18 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1993-06-18 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1993-06-18 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1993-06-18 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1993-06-18 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1993-06-18 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1993-06-18 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1993-06-18 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1993-06-18 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1993-06-18 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1993-06-18 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1993-06-18 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1993-06-18 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N019287-001 | DIZAC | 5MG/ML | INJECTABLE / INJECTION | 1993-06-18 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N019287-001 | DIZAC | 5MG/ML | INJECTABLE / INJECTION | 1993-06-18 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | 1993-06-18 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1993-06-18 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | 1993-06-18 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | 1993-06-18 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | 1993-06-18 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | 1993-06-18 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | 1993-06-18 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | 1993-06-18 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | 1993-06-18 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | 1993-06-18 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1993-06-18 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1993-06-18 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1993-06-18 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1993-06-18 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1993-06-18 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1993-06-18 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1993-06-18 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1993-06-18 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1993-06-18 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N019287-001 | DIZAC | 5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE / INJECTION | 1993-06-18 | 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 |
|---|---|---|---|---|---|---|
| Diazepam | DIAZEPAM | Alembic Pharmaceuticals Inc. | 6b6ca65b-4ede-47b9-bbf3-05bb67c0c71d | 2024-04-29 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| Diazepam | DIAZEPAM | Alembic Pharmaceuticals Limited | 1632f040-3b2c-43da-a42f-f2baf5ec778a | 2024-04-29 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| Diazepam | DIAZEPAM | Hikma Pharmaceuticals USA Inc. | 2719720b-4918-4f08-b1de-b267f404505f | 2024-04-09 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| Diazepam | DIAZEPAM | Bryant Ranch Prepack | 04cc10ad-7d5c-434e-9b29-85b14071492b | 2024-04-04 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| Diazepam | DIAZEPAM | Bryant Ranch Prepack | 078bbb41-7e3a-48db-87f0-ec6a6ec0194e | 2024-04-03 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| Diazepam | DIAZEPAM | Bryant Ranch Prepack | e8e4d5f5-3b4c-4c0f-a818-9da86389473c | 2024-04-02 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| Diazepam | DIAZEPAM | A-S Medication Solutions | af9a7906-4dca-4c1f-b16b-9b666a86b363 | 2024-02-18 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| Diazepam | DIAZEPAM | Teva Pharmaceuticals USA, Inc. | 48aa32cb-047a-414a-822e-82a5f26d8817 | 2024-01-31 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| Diazepam | DIAZEPAM | Clinical Solutions Wholesale, LLC | 8b4946b3-ae6c-4174-bbd8-0b8ed2c8fdf3 | 2024-01-09 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| Diazepam | DIAZEPAM | Clinical Solutions Wholesale, LLC | 83c1f93b-0fc6-4512-9c8f-9167b217d7f9 | 2024-01-09 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| Diazepam | DIAZEPAM | Clinical Solutions Wholesale, LLC | 87b0fbb9-0c05-4ab0-8efe-7ffcae85b868 | 2024-01-09 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| Diazepam | DIAZEPAM | Hospira, Inc. | 41044928-dd1f-40bf-1fa6-709dff559124 | 2024-01-05 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| Diazepam | DIAZEPAM | Oceanside Pharmaceuticals | b1b2848b-b265-4f6f-9141-bf106dec0726 | 2024-01-04 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| Diazepam | DIAZEPAM | Meridian Medical Technologies LLC | fa352464-14c8-49e9-b8b7-5a968b1cfa93 | 2023-12-18 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| DIAZEPAM | DIAZEPAM | Aurobindo Pharma Limited | 2f799120-0d08-47cd-8183-a98f0267c845 | 2023-12-15 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| Diazepam | DIAZEPAM | Bryant Ranch Prepack | f2fc6f38-d627-4fb3-9be2-5e119ee7e1e1 | 2023-12-11 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| Diazepam | DIAZEPAM | American Health Packaging | aeadf0b0-918b-40e0-a5e8-60b2fcbd5ded | 2023-08-10 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| Diazepam | DIAZEPAM | Medical Purchasing Solutions, LLC | c8e979a8-af6b-f0c4-e053-2995a90ae63f | 2023-05-03 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| Diazepam | DIAZEPAM | Medical Purchasing Solutions, LLC | c8e95ff5-c177-1ec3-e053-2995a90a6d78 | 2023-04-27 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| Diazepam | DIAZEPAM | Aphena Pharma Solutions - Tennessee, LLC | 9cf031ae-d59b-430d-9b15-415ae2e49c98 | 2022-09-02 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.