Application 208829
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS CO
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 |
|---|---|---|---|---|---|---|---|
| A208829-001 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2017-05-24 | ||
| A208829-002 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | 2017-05-24 | ||
| A208829-003 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2017-05-24 | ||
| A208829-004 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2017-05-24 | ||
| A208829-005 | BUSPIRONE HYDROCHLORIDE | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2017-05-24 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A208829-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2017-05-24 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A208829-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | 2017-05-24 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A208829-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2017-05-24 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A208829-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2017-05-24 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A208829-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2017-05-24 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A208829-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2017-05-24 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A208829-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | 2017-05-24 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A208829-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2017-05-24 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A208829-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2017-05-24 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A208829-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2017-05-24 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A208829-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2017-05-24 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A208829-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | 2017-05-24 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A208829-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2017-05-24 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A208829-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2017-05-24 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A208829-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2017-05-24 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208829-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2017-05-24 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208829-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | 2017-05-24 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208829-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2017-05-24 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208829-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2017-05-24 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A208829-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2017-05-24 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208829-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2017-05-24 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208829-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | 2017-05-24 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208829-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2017-05-24 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208829-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2017-05-24 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A208829-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2017-05-24 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208829-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2017-05-24 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208829-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | 2017-05-24 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208829-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2017-05-24 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208829-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2017-05-24 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A208829-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2017-05-24 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208829-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2017-05-24 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208829-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | 2017-05-24 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208829-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2017-05-24 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208829-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2017-05-24 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A208829-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2017-05-24 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208829-001 | BUSPIRONE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2017-05-24 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208829-002 | BUSPIRONE HYDROCHLORIDE | 7.5MG | TABLET / ORAL | 2017-05-24 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208829-003 | BUSPIRONE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2017-05-24 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208829-004 | BUSPIRONE HYDROCHLORIDE | 15MG | TABLET / ORAL | 2017-05-24 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A208829-005 | BUSPIRONE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2017-05-24 | 03ed91905a0d… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208829-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208829-002 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208829-003 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208829-004 | AB | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A208829-005 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A208829-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A208829-002 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A208829-003 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A208829-004 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A208829-005 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A208829-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A208829-002 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A208829-003 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A208829-004 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A208829-005 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A208829-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A208829-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A208829-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A208829-004 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A208829-005 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A208829-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A208829-002 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A208829-003 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A208829-004 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A208829-005 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A208829-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A208829-002 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A208829-003 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A208829-004 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A208829-005 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A208829-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A208829-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A208829-003 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A208829-004 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A208829-005 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A208829-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A208829-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A208829-003 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A208829-004 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A208829-005 | AB | 1 | 5aa47cf7b7d7… |
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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 50090-4657 | busPIRone HCl | buspirone hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4657 | busPIRone HCl | buspirone hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-4657 | busPIRone HCl | buspirone hydrochloride | A-S Medication Solutions | ANDA | Current |
| 55700-803 | busPIRone HCl | buspirone hydrochloride | Quality Care Products, LLC | ANDA | Current |
| 69238-1115 | busPIRone HCl | buspirone hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1115 | busPIRone HCl | buspirone hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1115 | busPIRone HCl | buspirone hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
| 69238-1115 | busPIRone HCl | buspirone hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1115 | busPIRone HCl | buspirone hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1116 | busPIRone HCl | buspirone hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1116 | busPIRone HCl | buspirone hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1116 | busPIRone HCl | buspirone hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
| 69238-1116 | busPIRone HCl | buspirone hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1116 | busPIRone HCl | buspirone hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1117 | busPIRone HCl | buspirone hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1117 | busPIRone HCl | buspirone hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1117 | busPIRone HCl | buspirone hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
| 69238-1117 | busPIRone HCl | buspirone hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1117 | busPIRone HCl | buspirone hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1118 | busPIRone HCl | buspirone hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1118 | busPIRone HCl | buspirone hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1118 | busPIRone HCl | buspirone hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
| 69238-1118 | busPIRone HCl | buspirone hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1118 | busPIRone HCl | buspirone hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1119 | busPIRone HCl | buspirone hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1119 | busPIRone HCl | buspirone hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1119 | busPIRone HCl | buspirone hydrochloride | Amneal Pharmaceuticals LLC | ANDA | Current |
| 69238-1119 | busPIRone HCl | buspirone hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 69238-1119 | busPIRone HCl | buspirone hydrochloride | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 71335-1390 | busPIRone HCl | buspirone hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1390 | busPIRone HCl | buspirone hydrochloride | Bryant Ranch Prepack | ANDA | Current |