Application 071135
- Type
- ANDA
- Sponsor
- MAYNE PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DIAZEPAM | DIAZEPAM | TABLET;ORAL | 5MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A071135-001 | DIAZEPAM | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A071135-001 | 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 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A071135-001 | DIAZEPAM | 5MG | TABLET / ORAL | AB | 1987-02-03 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A071135-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A071135-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A071135-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071135-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A071135-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071135-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071135-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071135-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071135-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071135-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071135-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A071135-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071135-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A071135-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A071135-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A071135-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A071135-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A071135-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A071135-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A071135-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A071135-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A071135-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A071135-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A071135-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A071135-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A071135-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A071135-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A071135-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A071135-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A071135-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A071135-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A071135-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A071135-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A071135-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A071135-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A071135-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A071135-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A071135-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A071135-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A071135-001 | AB | 1 | f41ea6bd6efb… |
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 | Henry Schein, Inc. | 52fc91f4-992f-47cb-a7d2-b26d74577481 | 2026-03-24 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM DIAZEPAM |
| Diazepam | DIAZEPAM | REMEDYREPACK INC. | d7a4b3c7-7021-4764-8c21-49e4bc6f6058 | 2026-03-12 | Boxed warning, Warnings, Adverse reactions | Diazepam DIAZEPAM |
| Diazepam | DIAZEPAM | Safecor Health, LLC | 8b51f4b3-a5e8-4400-b624-ac0c47630c86 | 2026-02-20 | Boxed warning, Warnings, Adverse reactions | Diazepam DIAZEPAM |
| Diazepam | DIAZEPAM | Henry Schein, Inc. | bfa85a63-967f-4176-a752-0bafabbaaae3 | 2026-02-19 | Boxed warning, Warnings, Adverse reactions | Diazepam DIAZEPAM |
| Diazepam | DIAZEPAM | Natco Pharma USA LLC | 6b8dc373-fa01-42c9-89af-4e00bf00180a | 2026-02-12 | Boxed warning, Warnings, Adverse reactions | Diazepam DIAZEPAM |
| Diazepam | DIAZEPAM | Sagent Pharmaceuticals | 7a912f1a-deee-46df-a8df-22a0afb06529 | 2026-02-04 | Boxed warning, Warnings, Adverse reactions | Diazepam DIAZEPAM |
| Diazepam | DIAZEPAM | Direct_Rx | 181cc7ac-5129-2200-e063-6394a90afd3a | 2026-01-20 | Boxed warning, Warnings, Adverse reactions | Diazepam DIAZEPAM |
| DIAZEPAM | DIAZEPAM | Direct_Rx | 4b0c9c0a-4274-4d56-a7a4-bc497916469c | 2026-01-08 | Warnings, Adverse reactions | DIAZEPAM DIAZEPAM |
| Diazepam | DIAZEPAM | Lupin Pharmaceuticals,Inc. | d99b68aa-b3dc-49c8-8894-3da255cd26b0 | 2025-12-10 | Boxed warning, Warnings, Adverse reactions | Diazepam DIAZEPAM |
| Diazepam | DIAZEPAM ORAL | Chartwell RX, LLC | cdb839fb-27e5-4a11-aed6-da0a7ab6e996 | 2025-12-03 | Boxed warning, Warnings, Adverse reactions | Diazepam |
| Valium | DIAZEPAM | Roche Laboratories Inc. | 554baee5-b171-4452-a50a-41a0946f956c | 2025-12-01 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM |
| DIAZEPAM | DIAZEPAM | Henry Schein, Inc. | dcf7bc20-6c57-491a-b9e3-f42bacff8b99 | 2025-11-18 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM DIAZEPAM |
| Diazepam | DIAZEPAM ORAL | Chartwell Governmental & Specialty RX, LLC. | 167ee280-be68-4a28-a7d8-de41df14bc48 | 2025-11-10 | Boxed warning, Warnings, Adverse reactions | Diazepam |
| DIAZEPAM | DIAZEPAM | ASCLEMED USA INC. | 426f3da1-4105-ba0a-e063-6294a90a7a86 | 2025-10-31 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM DIAZEPAM |
| Diazepam | DIAZEPAM | A-S Medication Solutions | 01f04ee4-fff9-499a-8213-984e16368084 | 2025-10-27 | Boxed warning, Warnings, Adverse reactions | Diazepam DIAZEPAM |
| Diazepam | DIAZEPAM | PD-Rx Pharmaceuticals, Inc. | c2768add-5e01-4ff4-afa3-230380d59a1f | 2025-10-20 | Boxed warning, Warnings, Adverse reactions | Diazepam DIAZEPAM |
| Diazepam | DIAZEPAM | PD-Rx Pharmaceuticals, Inc. | 1ad84940-40f7-457a-8ffa-53e1a7bfee16 | 2025-10-17 | Boxed warning, Warnings, Adverse reactions | Diazepam DIAZEPAM |
| Diazepam | DIAZEPAM | PD-Rx Pharmaceuticals, Inc. | 2483426d-3782-432a-8b8d-86c06ef0de4a | 2025-10-17 | Boxed warning, Warnings, Adverse reactions | Diazepam DIAZEPAM |
| Diazepam | DIAZEPAM | PD-Rx Pharmaceuticals, Inc. | 84cecab3-d0e6-436b-996b-0b598e972308 | 2025-10-17 | Boxed warning, Warnings, Adverse reactions | Diazepam DIAZEPAM |
| Diazepam | DIAZEPAM | Natco Pharma USA LLC | 19d0e3e5-f081-4574-9f0a-e7e97a88c7a9 | 2025-09-08 | Boxed warning, Warnings, Adverse reactions | Diazepam DIAZEPAM |
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 |
|---|---|---|---|---|---|
| 0904-5880 | Diazepam | Diazepam | Major Pharmaceuticals | ANDA | Current |
| 0904-5880 | Diazepam | Diazepam | Major Pharmaceuticals | ANDA | Current |
| 35356-716 | Diazepam | Diazepam | Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC | ANDA | Current |
| 43063-887 | Diazepam | Diazepam | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-887 | Diazepam | Diazepam | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43353-278 | Diazepam | Diazepam | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 45865-482 | Diazepam | Diazepam | Medsource Pharmaceuticals | ANDA | Current |
| 50090-2995 | Diazepam | Diazepam | A-S Medication Solutions | ANDA | Current |
| 51862-063 | Diazepam | Diazepam | Mayne Pharma | ANDA | Current |
| 51862-063 | Diazepam | Diazepam | Mayne Pharma | ANDA | Current |
| 51862-063 | Diazepam | Diazepam | Mayne Pharma | ANDA | Current |
| 51862-063 | Diazepam | Diazepam | Mayne Pharma | ANDA | Current |
| 51862-063 | Diazepam | Diazepam | Mayne Pharma | ANDA | Current |
| 51862-942 | Diazepam | Diazepam | Mayne Pharma | ANDA | Current |
| 51862-942 | Diazepam | Diazepam | Mayne Pharma | ANDA | Current |
| 51862-942 | Diazepam | Diazepam | Mayne Pharma | ANDA | Current |
| 51862-942 | Diazepam | Diazepam | Mayne Pharma | ANDA | Current |
| 52959-047 | DIAZEPAM | DIAZEPAM | H.J. Harkins Company, Inc. | ANDA | Current |
| 55154-1492 | Diazepam | Diazepam | Cardinal Health | ANDA | Current |
| 55154-7885 | Diazepam | Diazepam | Cardinal Health | ANDA | Current |
| 55700-439 | Diazepam | Diazepam | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 60760-934 | Diazepam | Diazepam | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 61919-088 | DIAZEPAM | DIAZEPAM | DIRECT RX | ANDA | Current |
| 61919-088 | DIAZEPAM | DIAZEPAM | Direct_Rx | ANDA | Current |
| 61919-088 | DIAZEPAM | DIAZEPAM | Direct_Rx | ANDA | Current |
| 61919-088 | DIAZEPAM | DIAZEPAM | Direct_Rx | ANDA | Current |
| 61919-367 | Diazepam | Diazepam | Direct Rx | ANDA | Current |
| 63187-867 | Diazepam | Diazepam | Proficient Rx LP | ANDA | Current |
| 63187-867 | Diazepam | Diazepam | Proficient Rx LP | ANDA | Current |
| 63739-073 | Diazepam | Diazepam | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-073 | Diazepam | Diazepam | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-073 | Diazepam | Diazepam | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-073 | Diazepam | Diazepam | McKesson Corporation | ANDA | Current |
| 66267-069 | Diazepam | Diazepam | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-069 | Diazepam | Diazepam | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-776 | Diazepam | Diazepam | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-776 | Diazepam | Diazepam | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 67046-941 | Diazepam | Diazepam | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-946 | Diazepam | Diazepam | Contract Pharmacy Services-PA | ANDA | Current |
| 67296-0506 | Diazepam | diazepam | RedPharm Drug Inc. | ANDA | Current |
| 67296-1349 | Diazepam | Diazepam | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1349 | Diazepam | Diazepam | RedPharm Drug, Inc. | ANDA | Current |
| 67544-019 | Diazepam | Diazepam | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 68071-2826 | Diazepam | Diazepam | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2828 | Diazepam | Diazepam | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3270 | Diazepam | Diazepam | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3270 | Diazepam | Diazepam | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3330 | Diazepam | Diazepam | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3330 | Diazepam | Diazepam | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68788-6851 | Diazepam | Diazepam | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6851 | Diazepam | Diazepam | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6851 | Diazepam | Diazepam | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8281 | Diazepam | Diazepam | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 71335-0495 | Diazepam | Diazepam | Bryant Ranch Prepack | ANDA | Current |
| 71335-0495 | Diazepam | Diazepam | Bryant Ranch Prepack | ANDA | Current |
| 71335-0495 | Diazepam | Diazepam | Bryant Ranch Prepack | ANDA | Current |
| 71335-0495 | Diazepam | Diazepam | Bryant Ranch Prepack | ANDA | Current |
| 71335-1627 | Diazepam | Diazepam | Bryant Ranch Prepack | ANDA | Current |
| 71335-2197 | Diazepam | Diazepam | Bryant Ranch Prepack | ANDA | Current |
| 71610-459 | Diazepam | Diazepam | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-459 | Diazepam | Diazepam | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-459 | Diazepam | Diazepam | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-459 | Diazepam | Diazepam | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 72189-401 | Valium | Diazepam | Direct_Rx | ANDA | Current |
| 72189-401 | Valium | Diazepam | Direct_Rx | ANDA | Current |