Application 218628
- Type
- ANDA
- Sponsor
- EPIC PHARMA LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | BUCAPSOL | BUSPIRONE HYDROCHLORIDE | CAPSULE;ORAL | 7.5MG | No | No |
| 002 | BUCAPSOL | BUSPIRONE HYDROCHLORIDE | CAPSULE;ORAL | 10MG | No | No |
| 003 | BUCAPSOL | BUSPIRONE HYDROCHLORIDE | CAPSULE;ORAL | 15MG | No | Yes |
| 004 | BUCAPSOL | BUSPIRONE HYDROCHLORIDE | CAPSULE;ORAL | 5MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A218628-001 | BUCAPSOL | BUSPIRONE HYDROCHLORIDE | 7.5MG | CAPSULE / ORAL | 2025-03-13 | ||
| A218628-002 | BUCAPSOL | BUSPIRONE HYDROCHLORIDE | 10MG | CAPSULE / ORAL | 2025-03-13 | ||
| A218628-003 | BUCAPSOL | BUSPIRONE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | RS | 2025-03-13 | |
| A218628-004 | BUCAPSOL | BUSPIRONE HYDROCHLORIDE | 5MG | CAPSULE / ORAL | 2026-04-29 |
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 | A218628-001 | BUCAPSOL | 7.5MG | CAPSULE / ORAL | 2025-03-13 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A218628-002 | BUCAPSOL | 10MG | CAPSULE / ORAL | 2025-03-13 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A218628-003 | BUCAPSOL | 15MG | CAPSULE / ORAL | RS | 2025-03-13 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218628-001 | BUCAPSOL | 7.5MG | CAPSULE / ORAL | 2025-03-13 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218628-002 | BUCAPSOL | 10MG | CAPSULE / ORAL | 2025-03-13 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218628-003 | BUCAPSOL | 15MG | CAPSULE / ORAL | RS | 2025-03-13 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A218628-001 | BUSPIRONE HYDROCHLORIDE | 7.5MG | CAPSULE / ORAL | 2025-03-13 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A218628-002 | BUSPIRONE HYDROCHLORIDE | 10MG | CAPSULE / ORAL | 2025-03-13 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A218628-003 | BUSPIRONE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | 2025-03-13 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218628-001 | BUSPIRONE HYDROCHLORIDE | 7.5MG | CAPSULE / ORAL | 2025-03-13 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218628-002 | BUSPIRONE HYDROCHLORIDE | 10MG | CAPSULE / ORAL | 2025-03-13 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218628-003 | BUSPIRONE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | 2025-03-13 | fd3edfee7708… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218628-001 | BUCAPSOL | 7.5MG | CAPSULE / ORAL | 2025-03-13 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218628-002 | BUCAPSOL | 10MG | CAPSULE / ORAL | 2025-03-13 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218628-003 | BUCAPSOL | 15MG | CAPSULE / ORAL | RS | 2025-03-13 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218628-004 | BUCAPSOL | 5MG | CAPSULE / ORAL | 2026-04-29 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Bucapsol | BUSPIRONE HYDROCHLORIDE | PANGEA PHARMACEUTICALS, LLC | f101c5f3-d533-474d-a8bf-90d054933d16 | 2026-07-13 | Warnings, Adverse reactions | 218628 ANDA218628 |
| Buspirone Hydrochloride | BUSPIRONE HYDROCHLORIDE | EPIC PHARMA, LLC | 160f52d2-2e08-4969-80c3-c653767652f0 | 2025-03-21 | Warnings, Adverse reactions | 218628 ANDA218628 |