Application 210156
- Type
- ANDA
- Sponsor
- TORRENT PHARMS LLC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | APIXABAN | APIXABAN | TABLET;ORAL | 2.5MG | No | No |
| 002 | APIXABAN | APIXABAN | TABLET;ORAL | 5MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A210156-001 | APIXABAN | APIXABAN | 2.5MG | TABLET / ORAL | 2024-12-17 | ||
| A210156-002 | APIXABAN | APIXABAN | 5MG | TABLET / ORAL | 2024-12-17 |
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 | A210156-001 | APIXABAN | 2.5MG | TABLET / ORAL | 2024-12-17 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A210156-002 | APIXABAN | 5MG | TABLET / ORAL | 2024-12-17 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210156-001 | APIXABAN | 2.5MG | TABLET / ORAL | 2024-12-17 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A210156-002 | APIXABAN | 5MG | TABLET / ORAL | 2024-12-17 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A210156-001 | APIXABAN | 2.5MG | TABLET / ORAL | 2024-12-17 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A210156-002 | APIXABAN | 5MG | TABLET / ORAL | 2024-12-17 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210156-001 | APIXABAN | 2.5MG | TABLET / ORAL | AB | 2024-12-17 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210156-002 | APIXABAN | 5MG | TABLET / ORAL | AB | 2024-12-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210156-001 | APIXABAN | 2.5MG | TABLET / ORAL | AB | 2024-12-17 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210156-002 | APIXABAN | 5MG | TABLET / ORAL | AB | 2024-12-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210156-001 | APIXABAN | 2.5MG | TABLET / ORAL | AB | 2024-12-17 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210156-002 | APIXABAN | 5MG | TABLET / ORAL | AB | 2024-12-17 | 03ed91905a0d… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A210156-001 | APIXABAN | 2.5MG | TABLET / ORAL | 2024-12-17 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A210156-002 | APIXABAN | 5MG | TABLET / ORAL | 2024-12-17 | a50c72e98297… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210156-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A210156-002 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210156-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A210156-002 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210156-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A210156-002 | AB | 1 | 03ed91905a0d… |
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 |
|---|---|---|---|---|---|---|
| ELIQUIS | APIXABAN | Cardinal Health 107, LLC | a454cd24-0c6d-46e8-b1e4-197388606175 | 2026-04-24 | Boxed warning, Warnings, Adverse reactions | APIXABAN |
| ELIQUIS | APIXABAN | REMEDYREPACK INC. | 7be1f4c1-bb2f-4ded-ae9a-515d2a22f93e | 2025-08-29 | Boxed warning, Warnings, Adverse reactions | APIXABAN |
| Apixaban | APIXABAN | Macleods Pharmaceuticals Limited | 396912c0-9f68-47ed-ba3f-8d9ace755a48 | 2025-04-03 | Boxed warning, Warnings, Adverse reactions | Apixaban APIXABAN |
| ELIQUIS | APIXABAN | Aphena Pharma Solutions - Tennessee, LLC | 1523ab32-2c2c-6501-e063-6394a90aa0b3 | 2025-02-03 | Boxed warning, Warnings, Adverse reactions | APIXABAN |
| ELIQUIS | APIXABAN | Aphena Pharma Solutions - Tennessee, LLC | 41a133ef-e461-48ad-8221-b735bdd0ec25 | 2025-01-30 | Boxed warning, Warnings, Adverse reactions | APIXABAN |
| ELIQUIS | APIXABAN | A-S Medication Solutions | 33a9046a-41cc-46c1-becc-2ff4d7d71538 | 2024-11-25 | Boxed warning, Warnings, Adverse reactions | APIXABAN |
| ELIQUIS | APIXABAN | Proficient Rx LP | 33752f5d-2ca7-45c0-8292-b54742219b97 | 2024-06-01 | Boxed warning, Warnings, Adverse reactions | APIXABAN |
| Apixaban | APIXABAN | Amneal Pharmaceuticals of New York LLC | 19a60552-374d-4b8b-a8ce-ceae252ea5ba | 2024-05-23 | Boxed warning, Warnings, Adverse reactions | Apixaban APIXABAN |
| ELIQUIS | APIXABAN | A-S Medication Solutions | 2f47aa0e-0235-4220-85dd-dfcb8ad0d009 | 2023-05-09 | Boxed warning, Warnings, Adverse reactions | APIXABAN |
| ELIQUIS | APIXABAN | A-S Medication Solutions | fd383ae7-1e34-44ef-b8f1-ca6906dfbcef | 2023-05-01 | Boxed warning, Warnings, Adverse reactions | APIXABAN |
| apixaban | APIXABAN | Indoco Remedies Limited | 095a08ac-cf0e-497e-a682-ddef38d6b29c | 2021-06-15 | Boxed warning, Warnings, Adverse reactions | apixaban APIXABAN |