Application 210907
- Type
- ANDA
- Sponsor
- UNICHEM LABS LTD
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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A210907-001 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-11-14 | |
| A210907-002 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-11-14 | |
| A210907-003 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | RS | 2019-11-14 |
| A210907-004 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-11-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A210907-001 | AB |
| A210907-002 | AB |
| A210907-003 | AB |
| A210907-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A210907-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-11-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210907-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-11-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A210907-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | RS | 2019-11-14 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210907-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-11-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210907-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-11-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210907-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-11-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210907-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | RS | 2019-11-14 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210907-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-11-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210907-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-11-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210907-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-11-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A210907-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | RS | 2019-11-14 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210907-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-11-14 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210907-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-11-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210907-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-11-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210907-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2019-11-14 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210907-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-11-14 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210907-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-11-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210907-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-11-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210907-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2019-11-14 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210907-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-11-14 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210907-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-11-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210907-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-11-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210907-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2019-11-14 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210907-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-11-14 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210907-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-11-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210907-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-11-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210907-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2019-11-14 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210907-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-11-14 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210907-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-11-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210907-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-11-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210907-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2019-11-14 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210907-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-11-14 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210907-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-11-14 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210907-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-11-14 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210907-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2019-11-14 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210907-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-11-14 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210907-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2019-11-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210907-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2019-11-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210907-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2019-11-14 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A210907-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2019-11-14 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A210907-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210907-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210907-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A210907-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210907-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210907-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210907-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210907-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A210907-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210907-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210907-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A210907-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210907-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210907-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210907-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210907-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210907-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210907-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210907-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210907-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210907-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210907-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210907-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210907-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210907-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210907-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210907-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A210907-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210907-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210907-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210907-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A210907-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210907-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210907-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210907-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A210907-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A210907-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A210907-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A210907-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A210907-004 | AB | 1 | d06236e962d9… |
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 | Unit Dose Solutions, Inc. | 544a4570-bd7f-72bb-e063-6394a90ab8d6 | 2026-06-15 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | REMEDYREPACK INC. | fbff8248-b73c-474e-907e-449f8316c629 | 2026-06-12 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Asclemed USA, Inc. | 97f2d082-0931-4e4f-a5be-7792e399e42b | 2026-05-04 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Coupler LLC | 510120d3-c922-a071-e063-6294a90af6a7 | 2026-05-04 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | REMEDYREPACK INC. | 5b4da3f8-a5ce-4699-92e1-37fb95e0af2d | 2026-04-23 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | REMEDYREPACK INC. | 6c6db7a9-a728-406a-81af-edd89e1cc26f | 2026-04-07 | Warnings, Adverse reactions | 210907 ANDA210907 70518-3279 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 824c80e6-d508-405f-8a4f-2f10df5a9dc8 | 2026-03-20 | Warnings, Adverse reactions | 210907 ANDA210907 68788-7952 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 187c315b-9c2c-485f-aa63-e399e0796e78 | 2026-03-20 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 068ee1a0-a77a-4803-bad9-18117d7fb358 | 2026-03-20 | Warnings, Adverse reactions | 210907 ANDA210907 68788-8086 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 18ddef0b-1451-4bea-94fb-b6ec27f4744b | 2026-01-14 | Warnings, Adverse reactions | 210907 ANDA210907 68788-7968 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | REMEDYREPACK INC. | ed2b56fe-e02f-46bc-808a-352f9bbb5b57 | 2025-09-25 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | A-S Medication Solutions | 48b4e52d-d4c4-4d24-a0ac-24316371cef0 | 2025-09-09 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Proficient Rx LP | 801803eb-be17-4064-8813-7ccf52316cde | 2025-08-01 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone HCL | BUSPIRONE HCL | Direct_Rx | 3246dd4d-f787-2f62-e063-6294a90a9cd2 | 2025-06-25 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone HCL | BUSPIRONE HCL | Direct_Rx | 37780596-3b6f-8d00-e063-6294a90ad4ad | 2025-06-13 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 335107c9-5799-c4df-e063-6294a90a5ca0 | 2025-04-21 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | b6352207-e708-44a7-8a63-93b96613e1e7 | 2025-03-27 | Warnings, Adverse reactions | 210907 ANDA210907 71335-1673 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Advanced Rx of Tennessee, LLC | 30c93022-4126-db8c-e063-6394a90a7579 | 2025-03-20 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone HCL | BUSPIRONE HCL | Direct_Rx | f71e019b-3928-f8eb-e053-6394a90a871e | 2025-02-28 | Warnings, Adverse reactions | 210907 ANDA210907 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | f98d258d-6479-253a-e053-6394a90acbb3 | 2025-02-10 | Warnings, Adverse reactions | 210907 ANDA210907 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 29300-244 | Buspirone Hydrochloride | Buspirone Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-244 | Buspirone Hydrochloride | Buspirone Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-244 | Buspirone Hydrochloride | Buspirone Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-245 | Buspirone Hydrochloride | Buspirone Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-245 | Buspirone Hydrochloride | Buspirone Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-245 | Buspirone Hydrochloride | Buspirone Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-246 | Buspirone Hydrochloride | Buspirone Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-246 | Buspirone Hydrochloride | Buspirone Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-246 | Buspirone Hydrochloride | Buspirone Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-247 | Buspirone Hydrochloride | Buspirone Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-247 | Buspirone Hydrochloride | Buspirone Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 29300-247 | Buspirone Hydrochloride | Buspirone Hydrochloride | Unichem Pharmaceuticals (USA), Inc. | ANDA | Current |
| 50090-5762 | Buspirone Hydrochloride | Buspirone Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5797 | Buspirone Hydrochloride | Buspirone Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 55700-869 | Buspirone Hydrochloride | Buspirone Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-869 | Buspirone Hydrochloride | Buspirone Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-869 | Buspirone Hydrochloride | Buspirone Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 55700-869 | Buspirone Hydrochloride | Buspirone Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 68071-2572 | Buspirone Hydrochloride | Buspirone Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7952 | Buspirone Hydrochloride | Buspirone Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7952 | Buspirone Hydrochloride | Buspirone Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7968 | Buspirone Hydrochloride | Buspirone Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7968 | Buspirone Hydrochloride | Buspirone Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8086 | Buspirone Hydrochloride | Buspirone Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8086 | Buspirone Hydrochloride | Buspirone Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-2803 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2803 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-3091 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-3091 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-3091 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-3279 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-3279 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 71335-1673 | Buspirone Hydrochloride | Buspirone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1749 | Buspirone Hydrochloride | Buspirone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1749 | Buspirone Hydrochloride | Buspirone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1924 | Buspirone Hydrochloride | Buspirone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-2060 | Buspirone Hydrochloride | Buspirone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 72189-235 | Buspirone Hcl | Buspirone Hcl | Direct Rx | ANDA | Current |
| 72189-235 | Buspirone Hcl | Buspirone Hcl | Direct Rx | ANDA | Current |
| 72189-235 | Buspirone Hcl | Buspirone Hcl | Direct Rx | ANDA | Current |