Application 218977
- Type
- ANDA
- Sponsor
- APOTEX
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PRUCALOPRIDE SUCCINATE | PRUCALOPRIDE SUCCINATE | TABLET;ORAL | EQ 1MG BASE | No | No |
| 002 | PRUCALOPRIDE SUCCINATE | PRUCALOPRIDE SUCCINATE | TABLET;ORAL | EQ 2MG BASE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A218977-001 | PRUCALOPRIDE SUCCINATE | PRUCALOPRIDE SUCCINATE | EQ 1MG BASE | TABLET / ORAL | AB | 2025-06-24 | |
| A218977-002 | PRUCALOPRIDE SUCCINATE | PRUCALOPRIDE SUCCINATE | EQ 2MG BASE | TABLET / ORAL | AB | 2025-06-24 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A218977-001 | AB |
| A218977-002 | 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 | A218977-001 | PRUCALOPRIDE SUCCINATE | EQ 1MG BASE | TABLET / ORAL | AB | 2025-06-24 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A218977-002 | PRUCALOPRIDE SUCCINATE | EQ 2MG BASE | TABLET / ORAL | AB | 2025-06-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218977-001 | PRUCALOPRIDE SUCCINATE | EQ 1MG BASE | TABLET / ORAL | AB | 2025-06-24 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218977-002 | PRUCALOPRIDE SUCCINATE | EQ 2MG BASE | TABLET / ORAL | AB | 2025-06-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A218977-001 | PRUCALOPRIDE SUCCINATE | EQ 1MG BASE | TABLET / ORAL | AB | 2025-06-24 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A218977-002 | PRUCALOPRIDE SUCCINATE | EQ 2MG BASE | TABLET / ORAL | AB | 2025-06-24 | 6a471c1ec25d… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218977-001 | PRUCALOPRIDE SUCCINATE | EQ 1MG BASE | TABLET / ORAL | AB | 2025-06-24 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218977-002 | PRUCALOPRIDE SUCCINATE | EQ 2MG BASE | TABLET / ORAL | AB | 2025-06-24 | 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 | A218977-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A218977-002 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218977-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218977-002 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A218977-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A218977-002 | AB | 1 | 6a471c1ec25d… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218977-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218977-002 | AB | 1 | a50c72e98297… |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Prucalopride | PRUCALOPRIDE | Apotex Corp. | 01dcea95-b391-79da-bbfe-412f39022e9a | 2025-12-04 | Warnings, Adverse reactions | 218977 ANDA218977 |
| Prucalopride | PRUCALOPRIDE | AvKARE | 3ac293af-5ce2-33f1-e063-6394a90aa01f | 2025-07-25 | Warnings, Adverse reactions | 218977 ANDA218977 |