Application 075022
- Type
- ANDA
- Sponsor
- TEVA
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 | Yes |
| 004 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | TABLET;ORAL | 30MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A075022-001 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-02-28 | |
| A075022-002 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-02-28 | |
| A075022-003 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-02-28 | |
| A075022-004 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2004-03-25 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A075022-001 | AB |
| A075022-002 | AB |
| A075022-003 | AB |
| A075022-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-11-12 20:34 UTC · 4 captures of this ZIP | 2022-11 | A075022-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-02-28 | 3a93d1ddd44b… | |
| 2022-11-12 20:34 UTC · 4 captures of this ZIP | 2022-11 | A075022-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-02-28 | 3a93d1ddd44b… | |
| 2022-11-12 20:34 UTC · 4 captures of this ZIP | 2022-11 | A075022-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-02-28 | 3a93d1ddd44b… | |
| 2022-11-12 20:34 UTC · 4 captures of this ZIP | 2022-11 | A075022-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2004-03-25 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A075022-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-02-28 | f41ea6bd6efb… | |
| 2022-10-28 04:53 UTC | 2022-10 | A075022-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-02-28 | f41ea6bd6efb… | |
| 2022-10-28 04:53 UTC | 2022-10 | A075022-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-02-28 | f41ea6bd6efb… | |
| 2022-10-28 04:53 UTC | 2022-10 | A075022-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2004-03-25 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A075022-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-02-28 | e64feba35796… | |
| 2022-09-29 23:25 UTC | 2022-09 | A075022-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-02-28 | e64feba35796… | |
| 2022-09-29 23:25 UTC | 2022-09 | A075022-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-02-28 | e64feba35796… | |
| 2022-09-29 23:25 UTC | 2022-09 | A075022-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2004-03-25 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A075022-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-02-28 | cb3db0bc1861… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A075022-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-02-28 | cb3db0bc1861… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A075022-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-02-28 | cb3db0bc1861… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A075022-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2004-03-25 | cb3db0bc1861… | |
| 2026-08-01 22:54:32 | 2026-06 | A075022-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-02-28 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A075022-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-02-28 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A075022-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-02-28 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A075022-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2004-03-25 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-11-12 20:34 UTC · 4 captures of this ZIP | 2022-11 | A075022-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 4 captures of this ZIP | 2022-11 | A075022-002 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 4 captures of this ZIP | 2022-11 | A075022-003 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 4 captures of this ZIP | 2022-11 | A075022-004 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A075022-001 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A075022-002 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A075022-003 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A075022-004 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A075022-001 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A075022-002 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A075022-003 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A075022-004 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A075022-001 | AB | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A075022-002 | AB | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A075022-003 | AB | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A075022-004 | AB | 1 | cb3db0bc1861… |
| 2026-08-01 22:54:32 | 2026-06 | A075022-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A075022-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A075022-003 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A075022-004 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Redpharm Drug | 5718bc19-07b2-b61d-e063-6394a90a6e80 | 2026-07-21 | Warnings, Adverse reactions | 075022 ANDA075022 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 459cc50d-0b18-ac1d-e063-6294a90ae7c4 | 2026-03-26 | Warnings, Adverse reactions | 075022 ANDA075022 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Northwind Health Company, LLC | ff02c7cb-f96a-4a3b-99a2-812cd78b345c | 2025-12-26 | Warnings, Adverse reactions | 075022 ANDA075022 51655-015 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Boswell Pharmacy Services LLC d/b/a BPS Wholesale | 438f5c4d-a009-b851-e063-6394a90a084a | 2025-11-13 | Warnings, Adverse reactions | 075022 ANDA075022 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 3b41fd76-c3cc-77f0-e063-6294a90aa778 | 2025-07-31 | Warnings, Adverse reactions | 075022 ANDA075022 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | A-S Medication Solutions | 4adc1750-b89e-473d-a18f-949423a2354f | 2025-01-08 | Warnings, Adverse reactions | 075022 ANDA075022 50090-4862 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | a8720833-3bbc-4714-b9b8-716c5e55410d | 2024-10-21 | Warnings, Adverse reactions | 075022 ANDA075022 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | d5fcc60d-5465-4075-948c-1aa4ff21af4c | 2024-09-27 | Warnings, Adverse reactions | 075022 ANDA075022 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 72bff09c-826e-4394-a7e7-41d56ce9605b | 2024-09-24 | Warnings, Adverse reactions | 075022 ANDA075022 0615-7689 0615-7718 0615-7714 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | db32a7ec-5b50-4305-8952-df22e7e871e2 | 2024-07-09 | Warnings, Adverse reactions | 075022 ANDA075022 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | A-S Medication Solutions | cff1c7b2-4edb-4b5a-9626-2f7b8671b015 | 2024-05-22 | Warnings, Adverse reactions | 075022 ANDA075022 50090-5886 |
| Buspirone Hydrochloride | BUSPIRONE | Boswell Pharmacy Services d/b/a BPS Wholesale | 18e90d65-4a3a-864e-e063-6294a90ae99d | 2024-05-15 | Warnings, Adverse reactions | 075022 ANDA075022 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | A-S Medication Solutions | 96789fdc-f3a0-4441-b9f4-2be2d9c6273b | 2023-10-16 | Warnings, Adverse reactions | 075022 ANDA075022 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Teva Pharmaceuticals USA, Inc. | 6fac36b4-b223-479e-913f-f8c9cdb9e119 | 2023-07-23 | Warnings, Adverse reactions | 075022 ANDA075022 0093-0053 0093-5200 0093-0054 0093-1003 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Proficient Rx LP | 864ddd0c-80e5-4b4b-84e9-7d66214464ae | 2023-05-01 | Warnings, Adverse reactions | 075022 ANDA075022 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Proficient Rx LP | 9a702362-39cb-4171-8d64-f37fa7e1f638 | 2022-08-01 | Warnings, Adverse reactions | 075022 ANDA075022 63187-402 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Proficient Rx LP | 69eb15e9-c33e-40a3-82d8-497dad13068d | 2022-04-01 | Warnings, Adverse reactions | 075022 ANDA075022 63187-904 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | efa03f52-430e-455a-bdca-7f9d422b7b19 | 2019-01-08 | Warnings, Adverse reactions | 075022 ANDA075022 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | b7e3a98c-9ec5-4c21-9218-0d53a555a75c | 2018-11-08 | Warnings, Adverse reactions | 075022 ANDA075022 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0093-0053 | Buspirone Hydrochloride | Buspirone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-0053 | Buspirone Hydrochloride | Buspirone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-0053 | Buspirone Hydrochloride | Buspirone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-0053 | Buspirone Hydrochloride | Buspirone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-0053 | Buspirone Hydrochloride | Buspirone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-0054 | Buspirone Hydrochloride | Buspirone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-0054 | Buspirone Hydrochloride | Buspirone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-0054 | Buspirone Hydrochloride | Buspirone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-0054 | Buspirone Hydrochloride | Buspirone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-0054 | Buspirone Hydrochloride | Buspirone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-1003 | Buspirone Hydrochloride | Buspirone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-1003 | Buspirone Hydrochloride | Buspirone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-1003 | Buspirone Hydrochloride | Buspirone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-1003 | Buspirone Hydrochloride | Buspirone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-1003 | Buspirone Hydrochloride | Buspirone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5200 | Buspirone Hydrochloride | Buspirone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5200 | Buspirone Hydrochloride | Buspirone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5200 | Buspirone Hydrochloride | Buspirone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5200 | Buspirone Hydrochloride | Buspirone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0093-5200 | Buspirone Hydrochloride | Buspirone Hydrochloride | Teva Pharmaceuticals USA, Inc. | ANDA | Current |
| 0615-7633 | Buspirone Hydrochloride | Buspirone Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7634 | Buspirone Hydrochloride | Buspirone Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7635 | Buspirone Hydrochloride | Buspirone Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7689 | Buspirone Hydrochloride | Buspirone Hydrochloride | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-7689 | Buspirone Hydrochloride | Buspirone Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7689 | Buspirone Hydrochloride | Buspirone Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7714 | Buspirone Hydrochloride | Buspirone Hydrochloride | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-7714 | Buspirone Hydrochloride | Buspirone Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7714 | Buspirone Hydrochloride | Buspirone Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7718 | Buspirone Hydrochloride | Buspirone Hydrochloride | NCS HealthCare of KY, LLC dba Vangard Labs | ANDA | Current |
| 0615-7718 | Buspirone Hydrochloride | Buspirone Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 0615-7718 | Buspirone Hydrochloride | Buspirone Hydrochloride | NCS HealthCare of KY, Inc dba Vangard Labs | ANDA | Current |
| 33261-014 | Buspirone Hydrochloride | Buspirone Hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 33261-015 | Buspirone Hydrochloride | Buspirone Hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 42254-126 | Buspirone Hydrochloride | Buspirone Hydrochloride | Rebel Distributors Corp | ANDA | Current |
| 42291-177 | Buspirone Hydrochloride | Buspirone Hydrochloride | AvKARE, Inc. | ANDA | Current |
| 42291-177 | Buspirone Hydrochloride | Buspirone Hydrochloride | AvKARE | ANDA | Current |
| 45865-887 | Buspirone Hydrochloride | Buspirone Hydrochloride | medsource pharmaceuticals | ANDA | Current |
| 50090-4182 | Buspirone Hydrochloride | Buspirone Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4182 | Buspirone Hydrochloride | Buspirone Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4182 | Buspirone Hydrochloride | Buspirone Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4862 | Buspirone Hydrochloride | Buspirone Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4862 | Buspirone Hydrochloride | Buspirone Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4862 | Buspirone Hydrochloride | Buspirone Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5886 | Buspirone Hydrochloride | Buspirone Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 51655-015 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | Northwind Pharmaceuticals, LLC | ANDA | Current |
| 52959-676 | Buspirone Hydrochloride | Buspirone Hydrochloride | H.J. Harkins Company, Inc. | ANDA | Current |
| 53002-1017 | Buspirone Hydrochloride | Buspirone Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1017 | Buspirone Hydrochloride | Buspirone Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 53002-1424 | Buspirone Hydrochloride | Buspirone Hydrochloride | RPK Pharmaceuticals, Inc. | ANDA | Current |
| 61919-579 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | Direct Rx | ANDA | Current |
| 61919-579 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | Direct Rx | ANDA | Current |
| 61919-579 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | Direct Rx | ANDA | Current |
| 61919-579 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | Direct Rx | ANDA | Current |
| 63187-402 | Buspirone Hydrochloride | Buspirone Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-402 | Buspirone Hydrochloride | Buspirone Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-402 | Buspirone Hydrochloride | Buspirone Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-904 | Buspirone Hydrochloride | Buspirone Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-904 | Buspirone Hydrochloride | Buspirone Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-904 | Buspirone Hydrochloride | Buspirone Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-904 | Buspirone Hydrochloride | Buspirone Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63629-1747 | Buspirone Hydrochloride | Buspirone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-3333 | Buspirone Hydrochloride | Buspirone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-3333 | Buspirone Hydrochloride | Buspirone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 67296-0925 | Buspirone Hydrochloride | Buspirone Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67296-0925 | Buspirone Hydrochloride | Buspirone Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 67296-0925 | Buspirone Hydrochloride | Buspirone Hydrochloride | RedPharm Drug, Inc. | ANDA | Current |
| 68151-1437 | Buspirone Hydrochloride | Buspirone Hydrochloride | Carilion Materials Management | ANDA | Current |
| 68151-1438 | Buspirone Hydrochloride | Buspirone Hydrochloride | Carilion Materials Management | ANDA | Current |
| 68788-5665 | Buspirone Hydrochloride | Buspirone Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9844 | Buspirone Hydrochloride | Buspirone Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9845 | Buspirone Hydrochloride | Buspirone Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-1687 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1687 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1747 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1747 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1747 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1747 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1924 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1924 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |