Application 018179
- Type
- NDA
- Sponsor
- ROCHE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VALRELEASE | DIAZEPAM | CAPSULE, EXTENDED RELEASE;ORAL | 15MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018179-001 | VALRELEASE | DIAZEPAM | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N018179-001 | VALRELEASE | 15MG | CAPSULE, EXTENDED RELEASE / ORAL | Approved before 1982 | e64feba35796… |
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 |
|---|---|---|---|---|---|---|
| Valium | DIAZEPAM | Waylis Therapuetics LLC | 260e2041-2bb3-482f-850e-b5d47a7bdbe6 | 2026-08-11 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| Diazepam | DIAZEPAM | REMEDYREPACK INC. | c57af2a2-aa9a-4dac-a200-e0d845005d05 | 2026-07-23 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| Diazepam | DIAZEPAM | REMEDYREPACK INC. | b4a045e4-d6ce-475d-abe4-590941bd3815 | 2026-07-21 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| Diazepam | DIAZEPAM | REMEDYREPACK INC. | 20e08b97-bb89-4129-a228-8ad9cf35a1d3 | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| Diazepam | DIAZEPAM | Hikma Pharmaceuticals USA Inc. | f466f8a3-f31c-44f4-b0e8-444464f20f66 | 2026-07-09 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| Diazepam | DIAZEPAM | REMEDYREPACK INC. | 5ebef149-1858-4199-aaed-7b9341fae63d | 2026-06-23 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| Diazepam | DIAZEPAM | Unit Dose Solutions, Inc. | 547c2ad4-113c-7771-e063-6394a90a2073 | 2026-06-17 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| Valtoco | DIAZEPAM | Neurelis, Inc | 1a8bcc90-68fa-474d-832c-0df01e825f39 | 2026-06-03 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| Diazepam | DIAZEPAM | Navinta LLC | b5b17a28-2cab-4c0d-8f9d-7b224e4d0989 | 2026-05-28 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| Diazepam | DIAZEPAM | Hospira, Inc. | 7e7dd743-a87b-4ab3-b6ae-f116cd0c8b0f | 2026-05-22 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| Diazepam | DIAZEPAM | Coupler LLC | 5111654f-a026-71b2-e063-6294a90ab49b | 2026-05-05 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| Diazepam | DIAZEPAM | Coupler LLC | 5114ae6e-8cae-e96f-e063-6294a90a9e60 | 2026-05-05 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| Diazepam | DIAZEPAM | Baxter Healthcare Corporation | a0813073-d0b0-4fd7-b307-56f69c910c82 | 2026-05-04 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| Diazepam | DIAZEPAM | Zydus Pharmaceuticals USA Inc. | 652714c7-25c4-4d05-979d-8eee3b6f2f4d | 2026-04-30 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| Diazepam | DIAZEPAM | Dr. Reddy's Laboratories Inc | 2a633cef-6dfc-4186-b595-174db2d8330e | 2026-04-29 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| Diazepam | DIAZEPAM | Dr. Reddy's Laboratories Inc | 9a860a4e-d670-d050-499d-eb1fd6b16176 | 2026-04-22 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| Diazepam | DIAZEPAM | Cardinal Health 107, LLC | ba953b22-f0cd-4be5-9e0e-178bded88727 | 2026-04-21 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| Diazepam | DIAZEPAM | Preferred Pharmaceuticals Inc. | 6dcbb5e9-1e8f-4069-9244-adb46356714d | 2026-04-01 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| Diazepam | DIAZEPAM | Preferred Pharmaceuticals Inc. | 7646785b-dabc-482d-bf42-06177f00aca2 | 2026-04-01 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| DIAZEPAM | DIAZEPAM | Henry Schein, Inc. | 52fc91f4-992f-47cb-a7d2-b26d74577481 | 2026-03-24 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |