Application 219332
- Type
- ANDA
- Sponsor
- ASCENT PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | RIVAROXABAN | RIVAROXABAN | TABLET;ORAL | 2.5MG | No | No |
| 002 | RIVAROXABAN | RIVAROXABAN | TABLET;ORAL | 10MG | No | No |
| 003 | RIVAROXABAN | RIVAROXABAN | TABLET;ORAL | 15MG | No | No |
| 004 | RIVAROXABAN | RIVAROXABAN | TABLET;ORAL | 20MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A219332-001 | RIVAROXABAN | RIVAROXABAN | 2.5MG | TABLET / ORAL | AB | 2025-05-14 | |
| A219332-002 | RIVAROXABAN | RIVAROXABAN | 10MG | TABLET / ORAL | AB | 2025-05-14 | |
| A219332-003 | RIVAROXABAN | RIVAROXABAN | 15MG | TABLET / ORAL | AB | 2025-05-14 | |
| A219332-004 | RIVAROXABAN | RIVAROXABAN | 20MG | TABLET / ORAL | AB | 2025-05-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A219332-001 | AB |
| A219332-002 | AB |
| A219332-003 | AB |
| A219332-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A219332-001 | RIVAROXABAN | 2.5MG | TABLET / ORAL | AB | 2025-05-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A219332-002 | RIVAROXABAN | 10MG | TABLET / ORAL | AB | 2025-05-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A219332-003 | RIVAROXABAN | 15MG | TABLET / ORAL | AB | 2025-05-14 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A219332-004 | RIVAROXABAN | 20MG | TABLET / ORAL | AB | 2025-05-14 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A219332-001 | RIVAROXABAN | 2.5MG | TABLET / ORAL | AB | 2025-05-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A219332-002 | RIVAROXABAN | 10MG | TABLET / ORAL | AB | 2025-05-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A219332-003 | RIVAROXABAN | 15MG | TABLET / ORAL | AB | 2025-05-14 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A219332-004 | RIVAROXABAN | 20MG | TABLET / ORAL | AB | 2025-05-14 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219332-001 | RIVAROXABAN | 2.5MG | TABLET / ORAL | AB | 2025-05-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219332-002 | RIVAROXABAN | 10MG | TABLET / ORAL | AB | 2025-05-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219332-003 | RIVAROXABAN | 15MG | TABLET / ORAL | AB | 2025-05-14 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219332-004 | RIVAROXABAN | 20MG | TABLET / ORAL | AB | 2025-05-14 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A219332-001 | RIVAROXABAN | 2.5MG | TABLET / ORAL | AB | 2025-05-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A219332-002 | RIVAROXABAN | 10MG | TABLET / ORAL | AB | 2025-05-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A219332-003 | RIVAROXABAN | 15MG | TABLET / ORAL | AB | 2025-05-14 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A219332-004 | RIVAROXABAN | 20MG | TABLET / ORAL | AB | 2025-05-14 | 6a471c1ec25d… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219332-001 | RIVAROXABAN | 2.5MG | TABLET / ORAL | AB | 2025-05-14 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219332-002 | RIVAROXABAN | 10MG | TABLET / ORAL | AB | 2025-05-14 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219332-003 | RIVAROXABAN | 15MG | TABLET / ORAL | AB | 2025-05-14 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219332-004 | RIVAROXABAN | 20MG | TABLET / ORAL | AB | 2025-05-14 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A219332-001 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A219332-002 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A219332-003 | AB | 1 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | A219332-004 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A219332-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A219332-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A219332-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A219332-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219332-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219332-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219332-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A219332-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A219332-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A219332-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A219332-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A219332-004 | AB | 1 | 6a471c1ec25d… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219332-001 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219332-002 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219332-003 | AB | 1 | a50c72e98297… |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A219332-004 | 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 |
|---|---|---|---|---|---|---|
| RIVAROXABAN | RIVAROXABAN | XLCare Pharmaceuticals, Inc. | 291011aa-60eb-4109-b59c-1c521fbeac4f | 2025-06-17 | Boxed warning, Warnings, Adverse reactions | 219332 ANDA219332 |
| RIVAROXABAN | RIVAROXABAN | Camber Pharmaceuticals, Inc. | 45f16f1b-e405-4aa6-bc8b-977d4864af3e | 2025-05-17 | Boxed warning, Warnings, Adverse reactions | 219332 ANDA219332 |