Application 202557
- Type
- ANDA
- Sponsor
- ACCORD HLTHCARE
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 | 7.5MG | No | No |
| 003 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 004 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | TABLET;ORAL | 15MG | No | No |
| 005 | 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 |
|---|---|---|---|---|---|---|---|
| A202557-001 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-12-30 | |
| A202557-002 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2014-12-30 | |
| A202557-003 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-12-30 | |
| A202557-004 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-12-30 | |
| A202557-005 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-12-30 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A202557-001 | AB |
| A202557-002 | AB |
| A202557-003 | AB |
| A202557-004 | AB |
| A202557-005 | 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 | A202557-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-12-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202557-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2014-12-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202557-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-12-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202557-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-12-30 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A202557-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-12-30 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202557-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-12-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202557-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2014-12-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202557-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-12-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202557-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-12-30 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202557-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-12-30 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202557-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-12-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202557-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2014-12-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202557-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-12-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202557-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2014-12-30 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A202557-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-12-30 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202557-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-12-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202557-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2014-12-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202557-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-12-30 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202557-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | RS | 2014-12-30 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202557-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-12-30 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202557-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-12-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202557-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2014-12-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202557-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-12-30 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202557-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | RS | 2014-12-30 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202557-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-12-30 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202557-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-12-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202557-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2014-12-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202557-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-12-30 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202557-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | RS | 2014-12-30 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202557-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-12-30 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202557-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-12-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202557-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2014-12-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202557-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-12-30 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202557-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | RS | 2014-12-30 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202557-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-12-30 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202557-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2014-12-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202557-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | AB | 2014-12-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202557-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2014-12-30 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202557-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | RS | 2014-12-30 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202557-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2014-12-30 | 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 | A202557-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202557-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202557-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202557-004 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A202557-005 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202557-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202557-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202557-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202557-004 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A202557-005 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A202557-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202557-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202557-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202557-004 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A202557-005 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202557-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202557-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202557-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202557-004 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A202557-005 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202557-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202557-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202557-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202557-004 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A202557-005 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202557-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202557-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202557-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202557-004 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A202557-005 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202557-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202557-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202557-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202557-004 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A202557-005 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202557-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202557-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202557-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202557-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A202557-005 | 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 | Bryant Ranch Prepack | 66df7f74-5dea-46d6-9ef8-9bab37baf407 | 2026-05-14 | Warnings, Adverse reactions | 202557 ANDA202557 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 7db10b76-4520-496e-b450-66a662cc95f6 | 2026-03-18 | Warnings, Adverse reactions | 202557 ANDA202557 43063-785 |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | DIRECT RX | bae98d45-e192-56e3-e053-2a95a90aadc3 | 2026-03-05 | Warnings, Adverse reactions | 202557 ANDA202557 |
| BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | Direct_Rx | 8e9c0553-c994-f54a-e053-2a95a90a6fa3 | 2026-01-08 | Warnings, Adverse reactions | 202557 ANDA202557 61919-166 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Northwind Health Company, LLC | f318ba7b-121f-2e4f-e053-2a95a90a60c5 | 2026-01-01 | Warnings, Adverse reactions | 202557 ANDA202557 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Accord Healthcare Inc. | 3da22999-f5fb-49fd-acde-c3006598e985 | 2025-10-07 | Warnings, Adverse reactions | 202557 ANDA202557 16729-289 16729-202 16729-201 16729-203 16729-200 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 540e9b7e-09ff-2cca-e054-00144ff8d46c | 2024-07-09 | Warnings, Adverse reactions | 202557 ANDA202557 68071-3336 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | A-S Medication Solutions | 4ae45cb1-8612-4006-b12c-2440160132ac | 2023-02-06 | Warnings, Adverse reactions | 202557 ANDA202557 50090-5614 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | fac49d42-7bc0-435f-bce2-2548dcdd6de6 | 2018-12-20 | Warnings, Adverse reactions | 202557 ANDA202557 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | 8b6e7ae6-5b83-4a5a-ab45-cf4be4287d78 | 2018-10-18 | Warnings, Adverse reactions | 202557 ANDA202557 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16729-200 | Buspirone Hydrochloride | Buspirone Hydrochloride | Accord Healthcare Inc. | ANDA | Current |
| 16729-200 | Buspirone Hydrochloride | Buspirone Hydrochloride | Accord Healthcare Inc. | ANDA | Current |
| 16729-200 | Buspirone Hydrochloride | Buspirone Hydrochloride | Accord Healthcare Inc. | ANDA | Current |
| 16729-200 | Buspirone Hydrochloride | Buspirone Hydrochloride | Accord Healthcare Inc. | ANDA | Current |
| 16729-201 | Buspirone Hydrochloride | Buspirone Hydrochloride | Accord Healthcare Inc. | ANDA | Current |
| 16729-201 | Buspirone Hydrochloride | Buspirone Hydrochloride | Accord Healthcare Inc. | ANDA | Current |
| 16729-201 | Buspirone Hydrochloride | Buspirone Hydrochloride | Accord Healthcare Inc. | ANDA | Current |
| 16729-201 | Buspirone Hydrochloride | Buspirone Hydrochloride | Accord Healthcare Inc. | ANDA | Current |
| 16729-202 | Buspirone Hydrochloride | Buspirone Hydrochloride | Accord Healthcare Inc. | ANDA | Current |
| 16729-202 | Buspirone Hydrochloride | Buspirone Hydrochloride | Accord Healthcare Inc. | ANDA | Current |
| 16729-202 | Buspirone Hydrochloride | Buspirone Hydrochloride | Accord Healthcare Inc. | ANDA | Current |
| 16729-202 | Buspirone Hydrochloride | Buspirone Hydrochloride | Accord Healthcare Inc. | ANDA | Current |
| 16729-203 | Buspirone Hydrochloride | Buspirone Hydrochloride | Accord Healthcare Inc. | ANDA | Current |
| 16729-203 | Buspirone Hydrochloride | Buspirone Hydrochloride | Accord Healthcare Inc. | ANDA | Current |
| 16729-203 | Buspirone Hydrochloride | Buspirone Hydrochloride | Accord Healthcare Inc. | ANDA | Current |
| 16729-203 | Buspirone Hydrochloride | Buspirone Hydrochloride | Accord Healthcare Inc. | ANDA | Current |
| 16729-289 | Buspirone Hydrochloride | Buspirone Hydrochloride | Accord Healthcare Inc. | ANDA | Current |
| 16729-289 | Buspirone Hydrochloride | Buspirone Hydrochloride | Accord Healthcare Inc. | ANDA | Current |
| 16729-289 | Buspirone Hydrochloride | Buspirone Hydrochloride | Accord Healthcare Inc. | ANDA | Current |
| 16729-289 | Buspirone Hydrochloride | Buspirone Hydrochloride | Accord Healthcare Inc. | ANDA | Current |
| 43063-785 | Buspirone Hydrochloride | Buspirone Hydrochloride | PD-Rx Pharmaceuticals, In | ANDA | Current |
| 43063-785 | Buspirone Hydrochloride | Buspirone Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-785 | Buspirone Hydrochloride | Buspirone Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-785 | Buspirone Hydrochloride | Buspirone Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-785 | Buspirone Hydrochloride | Buspirone Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-785 | Buspirone Hydrochloride | Buspirone Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 50090-3168 | Buspirone Hydrochloride | Buspirone Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3168 | Buspirone Hydrochloride | Buspirone Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3260 | Buspirone Hydrochloride | Buspirone Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3260 | Buspirone Hydrochloride | Buspirone Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5136 | Buspirone Hydrochloride | Buspirone Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5136 | Buspirone Hydrochloride | Buspirone Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-5614 | Buspirone Hydrochloride | Buspirone Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50436-2010 | Buspirone Hydrochloride | Buspirone Hydrochloride | Unit Dose Services | ANDA | Current |
| 55700-529 | Buspirone Hydrochloride | Buspirone Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-529 | Buspirone Hydrochloride | Buspirone Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-530 | Buspirone Hydrochloride | Buspirone Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 55700-530 | Buspirone Hydrochloride | Buspirone Hydrochloride | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 60760-548 | Buspirone Hydrochloride | Buspirone Hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 60760-548 | Buspirone Hydrochloride | Buspirone Hydrochloride | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 61919-166 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | DIRECT RX | ANDA | Current |
| 61919-166 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-166 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-166 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 61919-166 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 63629-7277 | Buspirone Hydrochloride | Buspirone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-7277 | Buspirone Hydrochloride | Buspirone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-7277 | Buspirone Hydrochloride | Buspirone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8037 | Buspirone Hydrochloride | Buspirone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 67046-322 | Buspirone Hydrochloride | Buspirone Hydrochloride | Contract Pharmacy Services-PA | ANDA | Current |
| 67046-349 | Buspirone Hydrochloride | Buspirone Hydrochloride | Contract Pharmacy Services-PA | ANDA | Current |
| 68071-3229 | Buspirone Hydrochloride | Buspirone Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3229 | Buspirone Hydrochloride | Buspirone Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3240 | Buspirone Hydrochloride | Buspirone Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-3336 | Buspirone Hydrochloride | Buspirone Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3336 | Buspirone Hydrochloride | Buspirone Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68788-6984 | Buspirone Hydrochloride | Buspirone Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6984 | Buspirone Hydrochloride | Buspirone Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6984 | Buspirone Hydrochloride | Buspirone Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6984 | Buspirone Hydrochloride | Buspirone Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-6984 | Buspirone Hydrochloride | Buspirone Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7017 | Buspirone Hydrochloride | Buspirone Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7017 | Buspirone Hydrochloride | Buspirone Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7017 | Buspirone Hydrochloride | Buspirone Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7462 | Buspirone Hydrochloride | Buspirone Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7462 | Buspirone Hydrochloride | Buspirone Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7462 | Buspirone Hydrochloride | Buspirone Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7462 | Buspirone Hydrochloride | Buspirone Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7571 | Buspirone Hydrochloride | Buspirone Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7571 | Buspirone Hydrochloride | Buspirone Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7571 | Buspirone Hydrochloride | Buspirone Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7571 | Buspirone Hydrochloride | Buspirone Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7885 | Buspirone Hydrochloride | Buspirone Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7885 | Buspirone Hydrochloride | Buspirone Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-0737 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-0737 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1243 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1243 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1243 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1404 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |