Application 210128
- Type
- ANDA
- Sponsor
- MYLAN
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 |
|---|---|---|---|---|---|---|---|
| A210128-001 | APIXABAN | APIXABAN | 2.5MG | TABLET / ORAL | 2019-12-23 | ||
| A210128-002 | APIXABAN | APIXABAN | 5MG | TABLET / ORAL | 2019-12-23 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-03-09 01:35 UTC | 2022-03 | A210128-001 | APIXABAN | 2.5MG | TABLET / ORAL | 2019-12-23 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A210128-002 | APIXABAN | 5MG | TABLET / ORAL | 2019-12-23 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A210128-001 | APIXABAN | 2.5MG | TABLET / ORAL | 2019-12-23 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A210128-002 | APIXABAN | 5MG | TABLET / ORAL | 2019-12-23 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A210128-001 | APIXABAN | 2.5MG | TABLET / ORAL | 2019-12-23 | 87673890dc5c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A210128-002 | APIXABAN | 5MG | TABLET / ORAL | 2019-12-23 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A210128-001 | APIXABAN | 2.5MG | TABLET / ORAL | 2019-12-23 | 5aa47cf7b7d7… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A210128-002 | APIXABAN | 5MG | TABLET / ORAL | 2019-12-23 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A210128-001 | APIXABAN | 2.5MG | TABLET / ORAL | 2019-12-23 | 8869cabd3fbd… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A210128-002 | APIXABAN | 5MG | TABLET / ORAL | 2019-12-23 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A210128-001 | APIXABAN | 2.5MG | TABLET / ORAL | 2019-12-23 | c0c555d07b60… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A210128-002 | APIXABAN | 5MG | TABLET / ORAL | 2019-12-23 | c0c555d07b60… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A210128-001 | APIXABAN | 2.5MG | TABLET / ORAL | 2019-12-23 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A210128-002 | APIXABAN | 5MG | TABLET / ORAL | 2019-12-23 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A210128-001 | APIXABAN | 2.5MG | TABLET / ORAL | 2019-12-23 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A210128-002 | APIXABAN | 5MG | TABLET / ORAL | 2019-12-23 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A210128-001 | APIXABAN | 2.5MG | TABLET / ORAL | 2019-12-23 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A210128-002 | APIXABAN | 5MG | TABLET / ORAL | 2019-12-23 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A210128-001 | APIXABAN | 2.5MG | TABLET / ORAL | 2019-12-23 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A210128-002 | APIXABAN | 5MG | TABLET / ORAL | 2019-12-23 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A210128-001 | APIXABAN | 2.5MG | TABLET / ORAL | 2019-12-23 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A210128-002 | APIXABAN | 5MG | TABLET / ORAL | 2019-12-23 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A210128-001 | APIXABAN | 2.5MG | TABLET / ORAL | 2019-12-23 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A210128-002 | APIXABAN | 5MG | TABLET / ORAL | 2019-12-23 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A210128-001 | APIXABAN | 2.5MG | TABLET / ORAL | 2019-12-23 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A210128-002 | APIXABAN | 5MG | TABLET / ORAL | 2019-12-23 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A210128-001 | APIXABAN | 2.5MG | TABLET / ORAL | 2019-12-23 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A210128-002 | APIXABAN | 5MG | TABLET / ORAL | 2019-12-23 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A210128-001 | APIXABAN | 2.5MG | TABLET / ORAL | 2019-12-23 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A210128-002 | APIXABAN | 5MG | TABLET / ORAL | 2019-12-23 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A210128-001 | APIXABAN | 2.5MG | TABLET / ORAL | 2019-12-23 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A210128-002 | APIXABAN | 5MG | TABLET / ORAL | 2019-12-23 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A210128-001 | APIXABAN | 2.5MG | TABLET / ORAL | 2019-12-23 | f41ea6bd6efb… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A210128-002 | APIXABAN | 5MG | TABLET / ORAL | 2019-12-23 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A210128-001 | APIXABAN | 2.5MG | TABLET / ORAL | 2019-12-23 | e64feba35796… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A210128-002 | APIXABAN | 5MG | TABLET / ORAL | 2019-12-23 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A210128-001 | APIXABAN | 2.5MG | TABLET / ORAL | 2019-12-23 | cb3db0bc1861… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A210128-002 | APIXABAN | 5MG | TABLET / ORAL | 2019-12-23 | cb3db0bc1861… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A210128-001 | APIXABAN | 2.5MG | TABLET / ORAL | 2019-12-23 | a50c72e98297… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A210128-002 | APIXABAN | 5MG | TABLET / ORAL | 2019-12-23 | 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 |
|---|---|---|---|---|---|---|
| ELIQUIS | APIXABAN | Cardinal Health 107, LLC | a454cd24-0c6d-46e8-b1e4-197388606175 | 2026-04-24 | Boxed warning, Warnings, Adverse reactions | APIXABAN |
| ELIQUIS | APIXABAN | Aphena Pharma Solutions - Tennessee, LLC | 1523ab32-2c2c-6501-e063-6394a90aa0b3 | 2025-02-03 | 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 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 59607 | ORIG | 2019-08-07 |