Application 218755
- Type
- ANDA
- Sponsor
- ESKAYEF
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PALIPERIDONE | PALIPERIDONE | TABLET, EXTENDED RELEASE;ORAL | 1.5MG | No | No |
| 002 | PALIPERIDONE | PALIPERIDONE | TABLET, EXTENDED RELEASE;ORAL | 3MG | No | No |
| 003 | PALIPERIDONE | PALIPERIDONE | TABLET, EXTENDED RELEASE;ORAL | 6MG | No | No |
| 004 | PALIPERIDONE | PALIPERIDONE | TABLET, EXTENDED RELEASE;ORAL | 9MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A218755-001 | PALIPERIDONE | PALIPERIDONE | 1.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-09-04 | |
| A218755-002 | PALIPERIDONE | PALIPERIDONE | 3MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-09-04 | |
| A218755-003 | PALIPERIDONE | PALIPERIDONE | 6MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-09-04 | |
| A218755-004 | PALIPERIDONE | PALIPERIDONE | 9MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-09-04 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A218755-001 | AB |
| A218755-002 | AB |
| A218755-003 | AB |
| A218755-004 | 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 | A218755-001 | PALIPERIDONE | 1.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-09-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218755-002 | PALIPERIDONE | 3MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-09-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218755-003 | PALIPERIDONE | 6MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-09-04 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218755-004 | PALIPERIDONE | 9MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-09-04 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218755-001 | PALIPERIDONE | 1.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-09-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218755-002 | PALIPERIDONE | 3MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-09-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218755-003 | PALIPERIDONE | 6MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-09-04 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218755-004 | PALIPERIDONE | 9MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-09-04 | 31067a03dcf5… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218755-001 | PALIPERIDONE | 1.5MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-09-04 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218755-002 | PALIPERIDONE | 3MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-09-04 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218755-003 | PALIPERIDONE | 6MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-09-04 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218755-004 | PALIPERIDONE | 9MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2025-09-04 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A218755-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218755-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218755-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218755-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218755-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218755-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218755-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218755-004 | AB | 1 | 31067a03dcf5… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218755-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218755-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218755-003 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218755-004 | AB | 1 | 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 |
|---|---|---|---|---|---|---|
| Paliperidone | PALIPERIDONE | Bryant Ranch Prepack | ff5ef11c-5c22-4a8e-89dd-4740f0ebf634 | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | 218755 ANDA218755 |
| Paliperidone | PALIPERIDONE | Bryant Ranch Prepack | f75e884e-1883-45d7-ac9b-4a6c63f2185e | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | 218755 ANDA218755 |
| Paliperidone | PALIPERIDONE | Bryant Ranch Prepack | f0c13f91-0232-48b0-aa13-121805b8da13 | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | 218755 ANDA218755 |
| Paliperidone | PALIPERIDONE | Bryant Ranch Prepack | c7472b50-fa6c-4127-a4b3-3645436274ee | 2026-05-27 | Boxed warning, Warnings, Adverse reactions | 218755 ANDA218755 |
| Paliperidone | PALIPERIDONE | Westminster Pharmaceuticals, LLC | 1745a460-5e3a-4a1f-8eb3-64bb112f47a4 | 2026-04-30 | Boxed warning, Warnings, Adverse reactions | 218755 ANDA218755 |
| PALIPERIDONE | PALIPERIDONE | Eskayef Pharmaceuticals Limited | de95e29f-a030-4777-a601-874500ab8e91 | 2025-09-08 | Boxed warning, Warnings, Adverse reactions | 218755 ANDA218755 |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 83306 | ORIG | 2025-09-08 |