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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A075022-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-02-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075022-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-02-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075022-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-02-28 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A075022-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2004-03-25 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075022-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-02-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075022-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-02-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075022-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-02-28 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075022-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2004-03-25 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075022-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-02-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075022-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-02-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075022-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-02-28 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A075022-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2004-03-25 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075022-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-02-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075022-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-02-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075022-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-02-28 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075022-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2004-03-25 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075022-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-02-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075022-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-02-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075022-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-02-28 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075022-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2004-03-25 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075022-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-02-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075022-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-02-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075022-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-02-28 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075022-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2004-03-25 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075022-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-02-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075022-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-02-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075022-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-02-28 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075022-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2004-03-25 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075022-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-02-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075022-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-02-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075022-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-02-28 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075022-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2004-03-25 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075022-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-02-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075022-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-02-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075022-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-02-28 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075022-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2004-03-25 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075022-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2002-02-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075022-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2002-02-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075022-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2002-02-28 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A075022-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2004-03-25 | 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 | A075022-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075022-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075022-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A075022-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075022-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075022-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075022-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A075022-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A075022-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075022-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075022-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A075022-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075022-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075022-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075022-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A075022-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075022-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075022-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075022-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A075022-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075022-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075022-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075022-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A075022-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075022-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075022-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075022-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A075022-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075022-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075022-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075022-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A075022-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075022-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075022-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075022-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A075022-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A075022-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075022-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075022-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A075022-004 | 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 | 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 |
| 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 |
| 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 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | db32a7ec-5b50-4305-8952-df22e7e871e2 | 2024-07-09 | Warnings, Adverse reactions | 075022 ANDA075022 71335-0253 71335-1105 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | A-S Medication Solutions | cff1c7b2-4edb-4b5a-9626-2f7b8671b015 | 2024-05-22 | Warnings, Adverse reactions | 075022 ANDA075022 |
| 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 |
| 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 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Proficient Rx LP | 69eb15e9-c33e-40a3-82d8-497dad13068d | 2022-04-01 | Warnings, Adverse reactions | 075022 ANDA075022 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | efa03f52-430e-455a-bdca-7f9d422b7b19 | 2019-01-08 | Warnings, Adverse reactions | 075022 ANDA075022 71610-203 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Aphena Pharma Solutions - Tennessee, LLC | b7e3a98c-9ec5-4c21-9218-0d53a555a75c | 2018-11-08 | Warnings, Adverse reactions | 075022 ANDA075022 71610-183 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 70518-2063 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2063 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2977 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2977 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 71335-0253 | Buspirone Hydrochloride | Buspirone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1105 | Buspirone Hydrochloride | Buspirone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71610-183 | Buspirone Hydrochloride | Buspirone Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 71610-203 | Buspirone Hydrochloride | Buspirone Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |