Application 078888
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 002 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 003 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | TABLET;ORAL | 15MG | No | No |
| 004 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | TABLET;ORAL | 30MG | No | No |
| 005 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | TABLET;ORAL | 7.5MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078888-001 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-02-07 | |
| A078888-002 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-02-07 | |
| A078888-003 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-02-07 | |
| A078888-004 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-02-07 | |
| A078888-005 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2023-03-21 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A078888-001 | AB |
| A078888-002 | AB |
| A078888-003 | AB |
| A078888-004 | AB |
| A078888-005 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078888-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-02-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078888-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-02-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078888-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-02-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078888-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-02-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A078888-005 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2023-03-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078888-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-02-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078888-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-02-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078888-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-02-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078888-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-02-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078888-005 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2023-03-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078888-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-02-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078888-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-02-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078888-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-02-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078888-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-02-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A078888-005 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2023-03-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078888-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-02-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078888-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-02-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078888-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-02-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078888-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-02-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078888-005 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2023-03-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078888-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-02-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078888-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-02-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078888-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-02-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078888-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-02-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078888-005 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2023-03-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078888-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-02-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078888-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-02-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078888-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-02-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078888-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-02-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078888-005 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2023-03-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078888-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-02-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078888-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-02-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078888-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-02-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078888-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-02-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078888-005 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2023-03-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078888-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-02-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078888-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-02-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078888-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-02-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078888-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-02-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078888-005 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2023-03-21 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A078888-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078888-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078888-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078888-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A078888-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078888-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078888-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078888-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078888-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078888-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A078888-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078888-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078888-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078888-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A078888-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078888-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078888-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078888-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078888-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078888-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078888-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078888-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078888-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078888-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078888-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078888-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078888-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078888-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078888-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078888-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078888-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078888-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078888-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078888-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078888-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078888-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078888-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078888-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078888-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078888-005 | AB | 1 | 5bbf6a4d5a75… |
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 |
|---|---|---|---|---|---|---|
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | Major Pharmaceuticals | a9bb9216-3dac-4e8a-9df9-f72c2eaef160 | 2026-06-30 | Warnings, Adverse reactions | 078888 ANDA078888 0904-6899 |
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | Unit Dose Solutions, Inc. | 544b8918-7175-655f-e063-6394a90a453a | 2026-06-15 | Warnings, Adverse reactions | 078888 ANDA078888 |
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | Coupler LLC | 53e7576a-e2f4-042b-e063-6294a90ae035 | 2026-06-10 | Warnings, Adverse reactions | 078888 ANDA078888 |
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | REMEDYREPACK INC. | fa3f9c0e-261d-4ceb-8cc7-e5e013563479 | 2026-06-10 | Warnings, Adverse reactions | 078888 ANDA078888 |
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | Cardinal Health 107, LLC | 1315494d-7a51-4395-bc7c-afb4bc5482c9 | 2026-04-24 | Warnings, Adverse reactions | 078888 ANDA078888 55154-3364 |
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | AvPAK | b230197c-3d50-7874-e053-2a95a90af50f | 2026-03-04 | Warnings, Adverse reactions | 078888 ANDA078888 50268-135 |
| buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | Zydus Lifesciences Limited | 1109dd63-6492-49b1-a383-3ab3a80cd6c7 | 2025-12-24 | 078888 ANDA078888 65841-783 65841-784 65841-781 65841-782 | |
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | 8c811d3a-8b2d-44f5-bc8f-8eb563f18c3f | 2025-11-10 | Warnings, Adverse reactions | 078888 ANDA078888 |
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | 08efb26e-488c-49d4-8432-98db855962e9 | 2025-03-31 | Warnings, Adverse reactions | 078888 ANDA078888 |
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | 897dac69-a59b-423c-be16-6301c7e504d9 | 2025-03-28 | Warnings, Adverse reactions | 078888 ANDA078888 |
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | Zydus Pharmaceuticals USA Inc. | 14fd7c1c-778e-46d4-9024-89b319f15f39 | 2025-02-12 | Warnings, Adverse reactions | 078888 ANDA078888 68382-181 68382-183 68382-180 68382-182 |
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | REMEDYREPACK INC. | 7ac98a7f-0ded-427f-899a-c3f6d1997403 | 2025-01-09 | Warnings, Adverse reactions | 078888 ANDA078888 70518-0380 |
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | American Health Packaging | e80d83a6-7c2a-478e-bdf1-c481824fc301 | 2024-06-07 | Warnings, Adverse reactions | 078888 ANDA078888 |
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | b07c0a91-892c-47f5-819e-a128e0ef1ed7 | 2023-12-15 | Warnings, Adverse reactions | 078888 ANDA078888 |
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 7f6986a8-59dc-4dc3-bac0-b38cfc689f8f | 2019-04-29 | Warnings, Adverse reactions | 078888 ANDA078888 |
| Buspirone hydrochloride | BUSPIRONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 310c6bea-838b-43e4-87e0-a0050829c242 | 2018-12-19 | Warnings, Adverse reactions | 078888 ANDA078888 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0904-6899 | Buspirone hydrochloride | Buspirone hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6899 | Buspirone hydrochloride | Buspirone hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-6899 | Buspirone hydrochloride | Buspirone hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 50090-2111 | Buspirone hydrochloride | Buspirone hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2111 | Buspirone hydrochloride | Buspirone hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2111 | Buspirone hydrochloride | Buspirone hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2111 | Buspirone hydrochloride | Buspirone hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50268-135 | Buspirone hydrochloride | Buspirone hydrochloride | AvPAK | ANDA | Current |
| 50268-135 | Buspirone hydrochloride | Buspirone hydrochloride | AvPAK | ANDA | Current |
| 50268-135 | Buspirone hydrochloride | Buspirone hydrochloride | AvPAK | ANDA | Current |
| 50436-0182 | Buspirone hydrochloride | Buspirone hydrochloride | Unit Dose Services | ANDA | Current |
| 53217-276 | Buspirone hydrochloride | Buspirone hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 55154-3364 | Buspirone hydrochloride | Buspirone hydrochloride | Cardinal Health | ANDA | Current |
| 55154-3364 | Buspirone hydrochloride | Buspirone hydrochloride | Cardinal Health 107, LLC | ANDA | Current |
| 55700-433 | Buspirone hydrochloride | Buspirone hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-526 | Buspirone hydrochloride | Buspirone hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-526 | Buspirone hydrochloride | Buspirone hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-526 | Buspirone hydrochloride | Buspirone hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-526 | Buspirone hydrochloride | Buspirone hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-526 | Buspirone hydrochloride | Buspirone hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 61919-600 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | DirectRX | ANDA | Current |
| 63629-6378 | Buspirone hydrochloride | Buspirone hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 65841-781 | buspirone hydrochloride | buspirone hydrochloride | Zydus Lifesciences Limited | ANDA | Current |
| 65841-781 | buspirone hydrochloride | buspirone hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 65841-781 | buspirone hydrochloride | buspirone hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 65841-781 | buspirone hydrochloride | buspirone hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 65841-782 | buspirone hydrochloride | buspirone hydrochloride | Zydus Lifesciences Limited | ANDA | Current |
| 65841-782 | buspirone hydrochloride | buspirone hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 65841-782 | buspirone hydrochloride | buspirone hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 65841-782 | buspirone hydrochloride | buspirone hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 65841-783 | buspirone hydrochloride | buspirone hydrochloride | Zydus Lifesciences Limited | ANDA | Current |
| 65841-783 | buspirone hydrochloride | buspirone hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 65841-783 | buspirone hydrochloride | buspirone hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 65841-783 | buspirone hydrochloride | buspirone hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 65841-784 | buspirone hydrochloride | buspirone hydrochloride | Zydus Lifesciences Limited | ANDA | Current |
| 65841-784 | buspirone hydrochloride | buspirone hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 65841-784 | buspirone hydrochloride | buspirone hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 65841-784 | buspirone hydrochloride | buspirone hydrochloride | Cadila Healthcare Limited | ANDA | Current |
| 66267-305 | Buspirone hydrochloride | Buspirone hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-528 | Buspirone hydrochloride | Buspirone hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-528 | Buspirone hydrochloride | Buspirone hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 66267-875 | Buspirone hydrochloride | Buspirone hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 66267-875 | Buspirone hydrochloride | Buspirone hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 67296-1520 | Buspirone hydrochloride | Buspirone hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1520 | Buspirone hydrochloride | Buspirone hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1520 | Buspirone hydrochloride | Buspirone hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 68382-180 | Buspirone hydrochloride | Buspirone hydrochloride | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-180 | Buspirone hydrochloride | Buspirone hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-180 | Buspirone hydrochloride | Buspirone hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-180 | Buspirone hydrochloride | Buspirone hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-181 | Buspirone hydrochloride | Buspirone hydrochloride | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-181 | Buspirone hydrochloride | Buspirone hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-181 | Buspirone hydrochloride | Buspirone hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-181 | Buspirone hydrochloride | Buspirone hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-182 | Buspirone hydrochloride | Buspirone hydrochloride | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-182 | Buspirone hydrochloride | Buspirone hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-182 | Buspirone hydrochloride | Buspirone hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-182 | Buspirone hydrochloride | Buspirone hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-183 | Buspirone hydrochloride | Buspirone hydrochloride | Zydus Pharmaceuticals USA Inc. | ANDA | Current |
| 68382-183 | Buspirone hydrochloride | Buspirone hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-183 | Buspirone hydrochloride | Buspirone hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-183 | Buspirone hydrochloride | Buspirone hydrochloride | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68788-6878 | Buspirone hydrochloride | Buspirone hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6878 | Buspirone hydrochloride | Buspirone hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6878 | Buspirone hydrochloride | Buspirone hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8929 | Buspirone hydrochloride | Buspirone hydrochloride | PreferredPharmaceuticals Inc. | ANDA | Current |
| 68788-8929 | Buspirone hydrochloride | Buspirone hydrochloride | PreferredPharmaceuticals Inc. | ANDA | Current |
| 68788-8929 | Buspirone hydrochloride | Buspirone hydrochloride | PreferredPharmaceuticals Inc. | ANDA | Current |
| 68788-8929 | Buspirone hydrochloride | Buspirone hydrochloride | PreferredPharmaceuticals Inc. | ANDA | Current |
| 68788-9766 | Buspirone hydrochloride | Buspirone hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-9766 | Buspirone hydrochloride | Buspirone hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-9766 | Buspirone hydrochloride | Buspirone hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-9766 | Buspirone hydrochloride | Buspirone hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-0380 | Buspirone hydrochloride | Buspirone hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0380 | Buspirone hydrochloride | Buspirone hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0380 | Buspirone hydrochloride | Buspirone hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0380 | Buspirone hydrochloride | Buspirone hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0380 | Buspirone hydrochloride | Buspirone hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1050 | Buspirone hydrochloride | Buspirone hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1050 | Buspirone hydrochloride | Buspirone hydrochloride | REMEDYREPACK INC. | ANDA | Current |