Application 204582
- Type
- ANDA
- Sponsor
- HERITAGE PHARMA
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 |
|---|---|---|---|---|---|---|---|
| A204582-001 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-09-18 | |
| A204582-002 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-09-18 | |
| A204582-003 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2015-09-18 | |
| A204582-004 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2015-09-18 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A204582-001 | AB |
| A204582-002 | AB |
| A204582-003 | AB |
| A204582-004 | 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 | A204582-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-09-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204582-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-09-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204582-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2015-09-18 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A204582-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2015-09-18 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204582-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-09-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204582-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-09-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204582-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2015-09-18 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204582-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2015-09-18 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204582-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-09-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204582-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-09-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204582-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2015-09-18 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A204582-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2015-09-18 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204582-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-09-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204582-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-09-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204582-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2015-09-18 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204582-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2015-09-18 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204582-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-09-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204582-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-09-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204582-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2015-09-18 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204582-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2015-09-18 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204582-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-09-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204582-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-09-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204582-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2015-09-18 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204582-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2015-09-18 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204582-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-09-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204582-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-09-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204582-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2015-09-18 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204582-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2015-09-18 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204582-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-09-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204582-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-09-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204582-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2015-09-18 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204582-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2015-09-18 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204582-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-09-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204582-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-09-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204582-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2015-09-18 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204582-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2015-09-18 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204582-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | AB | 2015-09-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204582-002 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | AB | 2015-09-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204582-003 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | AB | 2015-09-18 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A204582-004 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | AB | 2015-09-18 | 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 | A204582-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204582-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204582-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A204582-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204582-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204582-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204582-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204582-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A204582-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204582-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204582-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A204582-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204582-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204582-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204582-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204582-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204582-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204582-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204582-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204582-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204582-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204582-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204582-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204582-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204582-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204582-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204582-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204582-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204582-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204582-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204582-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204582-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204582-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204582-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204582-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204582-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A204582-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204582-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204582-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A204582-004 | 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 | REMEDYREPACK INC. | fd05160d-24c6-4371-8b2c-c0f78c8b468e | 2026-07-28 | Warnings, Adverse reactions | 204582 ANDA204582 70518-2660 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | REMEDYREPACK INC. | a9fc7091-b3ce-45fd-8d89-aeebdd81c327 | 2026-07-16 | Warnings, Adverse reactions | 204582 ANDA204582 70518-2031 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | 225575f1-9635-4922-8286-d479d6480bf0 | 2026-05-13 | Warnings, Adverse reactions | 204582 ANDA204582 71335-1605 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Bryant Ranch Prepack | eee7fa99-a9a1-4299-8a3d-6c2dd90948c9 | 2026-05-13 | Warnings, Adverse reactions | 204582 ANDA204582 71335-1608 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Cardinal Health 107, LLC | 5424f933-93e1-4480-acdf-bd8667ae50e9 | 2026-04-15 | Warnings, Adverse reactions | 204582 ANDA204582 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Northwind Health Company, LLC | 1d883a13-4877-c6c7-e063-6294a90a5137 | 2025-12-26 | Warnings, Adverse reactions | 204582 ANDA204582 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 4ff72575-bd60-40ce-b3a8-fd92b79af674 | 2025-11-07 | Warnings, Adverse reactions | 204582 ANDA204582 23155-097 23155-024 23155-025 23155-023 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | Major Pharmaceuticals | 8dc1ee33-e5aa-4462-8fb9-9bbdf5463488 | 2025-07-03 | Warnings, Adverse reactions | 204582 ANDA204582 0904-7121 0904-7122 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0904-7121 | Buspirone Hydrochloride | Buspirone Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 0904-7122 | Buspirone Hydrochloride | Buspirone Hydrochloride | Major Pharmaceuticals | ANDA | Current |
| 23155-023 | Buspirone Hydrochloride | Buspirone Hydrochloride | Heritage Pharmaceuticals Inc. | ANDA | Current |
| 23155-023 | Buspirone Hydrochloride | Buspirone Hydrochloride | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 23155-023 | Buspirone Hydrochloride | Buspirone Hydrochloride | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 23155-023 | Buspirone Hydrochloride | Buspirone Hydrochloride | Heritage Pharmaceuticals Inc. | ANDA | Current |
| 23155-024 | Buspirone Hydrochloride | Buspirone Hydrochloride | Heritage Pharmaceuticals Inc. | ANDA | Current |
| 23155-024 | Buspirone Hydrochloride | Buspirone Hydrochloride | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 23155-024 | Buspirone Hydrochloride | Buspirone Hydrochloride | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 23155-024 | Buspirone Hydrochloride | Buspirone Hydrochloride | Heritage Pharmaceuticals Inc. | ANDA | Current |
| 23155-025 | Buspirone Hydrochloride | Buspirone Hydrochloride | Heritage Pharmaceuticals Inc. | ANDA | Current |
| 23155-025 | Buspirone Hydrochloride | Buspirone Hydrochloride | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 23155-025 | Buspirone Hydrochloride | Buspirone Hydrochloride | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 23155-025 | Buspirone Hydrochloride | Buspirone Hydrochloride | Heritage Pharmaceuticals Inc. | ANDA | Current |
| 23155-097 | Buspirone Hydrochloride | Buspirone Hydrochloride | Heritage Pharmaceuticals Inc. | ANDA | Current |
| 23155-097 | Buspirone Hydrochloride | Buspirone Hydrochloride | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 23155-097 | Buspirone Hydrochloride | Buspirone Hydrochloride | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | ANDA | Current |
| 23155-097 | Buspirone Hydrochloride | Buspirone Hydrochloride | Heritage Pharmaceuticals Inc. | ANDA | Current |
| 55700-861 | Buspirone Hydrochloride | Buspirone Hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 67046-558 | Buspirone Hydrochloride | Buspirone Hydrochloride | Contract Pharmacy Services-PA | ANDA | Current |
| 70518-1940 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1940 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1940 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-1940 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2031 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2031 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2031 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2031 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2031 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2031 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2300 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2300 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2300 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2591 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2591 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2591 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2591 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2660 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2660 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2660 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2660 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2724 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2724 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2724 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 70518-2724 | Buspirone Hydrochloride | Buspirone Hydrochloride | REMEDYREPACK INC. | ANDA | Current |
| 71335-1605 | Buspirone Hydrochloride | Buspirone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1605 | Buspirone Hydrochloride | Buspirone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1605 | Buspirone Hydrochloride | Buspirone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1608 | Buspirone Hydrochloride | Buspirone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1608 | Buspirone Hydrochloride | Buspirone Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71610-267 | Buspirone Hydrochloride | Buspirone Hydrochloride | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 32569 | ORIG | 2015-09-24 |