Application 210301
- Type
- ANDA
- Sponsor
- ALEMBIC PHARMS LTD
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 |
|---|---|---|---|---|---|---|---|
| A210301-001 | RIVAROXABAN | RIVAROXABAN | 2.5MG | TABLET / ORAL | AB | 2025-05-14 | |
| A210301-002 | RIVAROXABAN | RIVAROXABAN | 10MG | TABLET / ORAL | AB | 2025-05-14 | |
| A210301-003 | RIVAROXABAN | RIVAROXABAN | 15MG | TABLET / ORAL | AB | 2025-05-14 | |
| A210301-004 | RIVAROXABAN | RIVAROXABAN | 20MG | TABLET / ORAL | AB | 2025-05-14 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A210301-001 | AB |
| A210301-002 | AB |
| A210301-003 | AB |
| A210301-004 | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A210301-001 | RIVAROXABAN | 2.5MG | TABLET / ORAL | AB | 2025-05-14 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A210301-002 | RIVAROXABAN | 10MG | TABLET / ORAL | AB | 2025-05-14 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A210301-003 | RIVAROXABAN | 15MG | TABLET / ORAL | AB | 2025-05-14 | a50c72e98297… | |
| 2026-08-01 22:54:32 | 2026-06 | A210301-004 | 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 |
|---|---|---|---|---|---|
| 2026-08-01 22:54:32 | 2026-06 | A210301-001 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A210301-002 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A210301-003 | AB | 1 | a50c72e98297… |
| 2026-08-01 22:54:32 | 2026-06 | A210301-004 | 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 |
|---|---|---|---|---|---|---|
| RIVAROXABAN | RIVAROXABAN | Alembic Pharmaceuticals Inc. | e62f23c6-89f2-4179-95dc-5732401b3f93 | 2026-04-15 | Boxed warning, Warnings, Adverse reactions | 210301 ANDA210301 |
| RIVAROXABAN | RIVAROXABAN | Alembic Pharmaceuticals Limited | 5524f30f-789d-4f5c-8f7c-d03a475b6d34 | 2025-11-21 | Boxed warning, Warnings, Adverse reactions | 210301 ANDA210301 |