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 | A-S Medication Solutions | ec433be5-d84d-425f-9edf-71263f885eec | 2025-08-13 | Boxed warning, Warnings, Adverse reactions | Diazepam DIAZEPAM |
| Diazepam | DIAZEPAM | Precision Dose Inc. | 78d5a77d-5ca7-4f16-b4d0-fce86456593c | 2025-08-07 | Boxed warning, Warnings, Adverse reactions | Diazepam DIAZEPAM |
| Diazepam | DIAZEPAM | Fresenius Kabi USA, LLC | ae52866a-0b9a-4baf-af1b-f9d5e00c0e56 | 2025-08-07 | Boxed warning, Warnings, Adverse reactions | Diazepam DIAZEPAM |
| Diazepam | DIAZEPAM | Mylan Institutional Inc. | b326c66d-5762-4d16-933c-619fa2088ccd | 2025-07-18 | Boxed warning, Warnings, Adverse reactions | Diazepam DIAZEPAM |
| Diazepam | DIAZEPAM | A-S Medication Solutions | b47dc708-e83b-4224-bdb5-c9b7abd35cfb | 2025-06-09 | Boxed warning, Warnings, Adverse reactions | Diazepam DIAZEPAM |
| Diazepam | DIAZEPAM | Natco Pharma USA LLC | a14f5930-a3ac-4996-9778-df5baa3d0bab | 2025-04-24 | Boxed warning, Warnings, Adverse reactions | Diazepam DIAZEPAM |
| DIAZEPAM | DIAZEPAM | Advanced Rx of Tennessee, LLC | 32c3af91-a57a-1278-e063-6294a90ae5ec | 2025-04-14 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM DIAZEPAM |
| Diazepam | DIAZEPAM | Advanced Rx of Tennessee, LLC | 2d322c6a-7f7e-1cc4-e063-6294a90a8e2e | 2025-04-14 | Boxed warning, Warnings, Adverse reactions | Diazepam DIAZEPAM |
| Diazepam | DIAZEPAM | Civica, Inc. | 83646a0f-eb43-4871-b95e-683c2533d2be | 2025-04-07 | Boxed warning, Warnings, Adverse reactions | Diazepam DIAZEPAM |
| Diazepam | DIAZEPAM | Asclemed USA, Inc. | 32e7bfa1-6060-4041-a0e5-249cacb84ebc | 2025-01-27 | Boxed warning, Warnings, Adverse reactions | Diazepam DIAZEPAM |
| DIAZEPAM | DIAZEPAM | Proficient Rx LP | 9322b0bc-e9fa-4c89-808b-110decf6db58 | 2025-01-01 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM DIAZEPAM |
| Diazepam | DIAZEPAM | Advanced Rx Pharmacy of Tennessee, LLC | b7002d26-3856-4c2f-e053-2995a90aea60 | 2024-12-31 | Boxed warning, Warnings, Adverse reactions | Diazepam DIAZEPAM |
| DIAZEPAM | DIAZEPAM | NuCare Pharmaceuticals, Inc. | 21785bb2-cc96-7973-e063-6294a90ab1b8 | 2024-12-26 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM DIAZEPAM |
| DIAZEPAM | DIAZEPAM | Sunrise Pharmaceutical, Inc. | 34ac0b9d-d4ad-4aaa-8bee-902365f4e9a8 | 2024-12-09 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM DIAZEPAM |
| Diazepam | DIAZEPAM | Hikma Pharmaceuticals USA Inc. | 9e85abed-1a8b-4762-a31f-f2c7f196b8af | 2024-12-04 | Boxed warning, Warnings, Adverse reactions | Diazepam DIAZEPAM |
| DIAZEPAM | DIAZEPAM | NuCare Pharmaceuticals, Inc | 22688087-27ad-620c-e063-6394a90a134c | 2024-10-08 | Boxed warning, Warnings, Adverse reactions | DIAZEPAM DIAZEPAM |
| Diazepam | DIAZEPAM | Bryant Ranch Prepack | 9424ce71-f04c-4d70-89de-b7858931c53d | 2024-08-23 | Boxed warning, Warnings, Adverse reactions | Diazepam DIAZEPAM |
| Diazepam | DIAZEPAM | Bryant Ranch Prepack | 632d7e96-d32c-45b8-86cf-f18ec2b35485 | 2024-08-23 | Boxed warning, Warnings, Adverse reactions | Diazepam DIAZEPAM |
| Diazepam | DIAZEPAM | Direct_rx | 2047f721-6a05-c391-e063-6394a90a4ed7 | 2024-08-22 | Boxed warning, Warnings, Adverse reactions | Diazepam DIAZEPAM |
| Diazepam | DIAZEPAM | NuCare Pharmaceuticals,Inc. | 823093aa-d0cd-53c9-e053-2a91aa0a5235 | 2024-06-14 | 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 |