Application 076008
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | TABLET;ORAL | 30MG | No | No |
| 002 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | TABLET;ORAL | 7.5MG | No | No |
| 003 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 004 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 005 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | TABLET;ORAL | 15MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076008-001 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2001-06-28 | |
| A076008-002 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | 2013-07-08 | ||
| A076008-003 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-03-01 | |
| A076008-004 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-03-01 | |
| A076008-005 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2001-03-28 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076008-001 | AB |
| A076008-003 | AB |
| A076008-004 | AB |
| A076008-005 | 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 | A076008-001 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2001-06-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076008-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2013-07-08 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076008-003 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076008-004 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-03-01 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076008-005 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2001-03-28 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076008-001 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2001-06-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076008-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2013-07-08 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076008-003 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-03-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076008-004 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-03-01 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076008-005 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2001-03-28 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076008-001 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2001-06-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076008-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2013-07-08 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076008-003 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-03-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076008-004 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-03-01 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076008-005 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2001-03-28 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076008-001 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2001-06-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076008-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2013-07-08 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076008-003 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-03-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076008-004 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-03-01 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076008-005 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2001-03-28 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076008-001 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2001-06-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076008-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2013-07-08 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076008-003 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-03-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076008-004 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-03-01 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076008-005 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2001-03-28 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076008-001 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2001-06-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076008-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2013-07-08 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076008-003 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-03-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076008-004 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-03-01 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076008-005 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2001-03-28 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076008-001 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2001-06-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076008-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2013-07-08 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076008-003 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-03-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076008-004 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-03-01 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076008-005 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2001-03-28 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076008-001 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2001-06-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076008-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2013-07-08 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076008-003 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-03-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076008-004 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-03-01 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076008-005 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2001-03-28 | 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 | A076008-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076008-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076008-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076008-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A076008-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076008-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076008-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076008-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076008-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076008-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076008-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076008-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076008-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076008-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A076008-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076008-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076008-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076008-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076008-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076008-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076008-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076008-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076008-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076008-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076008-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076008-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076008-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076008-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076008-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076008-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076008-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076008-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076008-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076008-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076008-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076008-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076008-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076008-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076008-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076008-005 | 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 | Cardinal Health 107, LLC | 2acc7da1-d5b8-4404-a3c6-d51ed82cc4fd | 2026-06-22 | Warnings, Adverse reactions | 076008 ANDA076008 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Mylan Pharmaceuticals Inc. | 7c9eafb9-9ce1-4b28-900c-8fcb4b23424e | 2026-06-15 | Warnings, Adverse reactions | 076008 ANDA076008 0378-1165 0378-1150 0378-1175 0378-1140 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Safecor Health, LLC | ebda05ee-d895-4636-bc28-d393e69c91b3 | 2026-02-20 | Warnings, Adverse reactions | 076008 ANDA076008 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Mylan Institutional Inc. | 91bb5fc9-5121-43c2-b2af-149240d4189a | 2025-07-18 | Warnings, Adverse reactions | 076008 ANDA076008 51079-960 51079-986 51079-985 51079-994 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-1140 | Buspirone Hydrochloride | buspirone hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1140 | Buspirone Hydrochloride | buspirone hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1140 | Buspirone Hydrochloride | buspirone hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1145 | Buspirone Hydrochloride | buspirone hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1145 | Buspirone Hydrochloride | buspirone hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1145 | Buspirone Hydrochloride | buspirone hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1150 | Buspirone Hydrochloride | buspirone hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1150 | Buspirone Hydrochloride | buspirone hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1150 | Buspirone Hydrochloride | buspirone hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1165 | Buspirone Hydrochloride | buspirone hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1165 | Buspirone Hydrochloride | buspirone hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1165 | Buspirone Hydrochloride | buspirone hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1175 | Buspirone Hydrochloride | buspirone hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1175 | Buspirone Hydrochloride | buspirone hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-1175 | Buspirone Hydrochloride | buspirone hydrochloride | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 21695-195 | Buspirone Hydrochloride | Buspirone Hydrochloride | Rebel Distributors Corp | ANDA | Current |
| 43353-060 | Buspirone Hydrochloride | buspirone hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-607 | Buspirone Hydrochloride | buspirone hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-609 | Buspirone Hydrochloride | buspirone hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 43353-610 | Buspirone Hydrochloride | buspirone hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 50090-2773 | Buspirone Hydrochloride | buspirone hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-2998 | Buspirone Hydrochloride | buspirone hydrochloride | A-S Medication Solutions | ANDA | Current |
| 51079-960 | Buspirone Hydrochloride | buspirone hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-960 | Buspirone Hydrochloride | buspirone hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-960 | Buspirone Hydrochloride | buspirone hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-985 | Buspirone Hydrochloride | buspirone hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-985 | Buspirone Hydrochloride | buspirone hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-985 | Buspirone Hydrochloride | buspirone hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-986 | Buspirone Hydrochloride | buspirone hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-986 | Buspirone Hydrochloride | buspirone hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-986 | Buspirone Hydrochloride | buspirone hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-994 | Buspirone Hydrochloride | buspirone hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-994 | Buspirone Hydrochloride | buspirone hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 51079-994 | Buspirone Hydrochloride | buspirone hydrochloride | Mylan Institutional Inc. | ANDA | Current |
| 55700-100 | Buspirone Hydrochloride | buspirone hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 60429-291 | Buspirone Hydrochloride | buspirone hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-292 | Buspirone Hydrochloride | buspirone hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-292 | Buspirone Hydrochloride | buspirone hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-292 | Buspirone Hydrochloride | buspirone hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-293 | Buspirone Hydrochloride | buspirone hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-293 | Buspirone Hydrochloride | buspirone hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-293 | Buspirone Hydrochloride | buspirone hydrochloride | Golden State Medical Supply, Inc. | ANDA | Current |
| 63629-6818 | Buspirone Hydrochloride | buspirone hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-6818 | Buspirone Hydrochloride | buspirone hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 67046-149 | Buspirone Hydrochloride | buspirone hydrochloride | Contract Pharmacy Services-PA | ANDA | Current |
| 70518-0203 | Buspirone Hydrochloride | buspirone hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0203 | Buspirone Hydrochloride | buspirone hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0264 | Buspirone Hydrochloride | buspirone hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0264 | Buspirone Hydrochloride | buspirone hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0401 | Buspirone Hydrochloride | buspirone hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0401 | Buspirone Hydrochloride | buspirone hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0401 | Buspirone Hydrochloride | buspirone hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0401 | Buspirone Hydrochloride | buspirone hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0641 | Buspirone Hydrochloride | buspirone hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0643 | Buspirone Hydrochloride | buspirone hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0681 | Buspirone Hydrochloride | buspirone hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0681 | Buspirone Hydrochloride | buspirone hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0681 | Buspirone Hydrochloride | buspirone hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0681 | Buspirone Hydrochloride | buspirone hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1820 | Buspirone Hydrochloride | buspirone hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-3165 | Buspirone Hydrochloride | buspirone hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 71335-2150 | Buspirone Hydrochloride | buspirone hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71610-360 | Buspirone Hydrochloride | buspirone hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |