Application 210259
- Type
- NDA
- Sponsor
- ASTRAZENECA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CALQUENCE | ACALABRUTINIB | CAPSULE;ORAL | 100MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0310-0512 | CALQUENCE | Acalabrutinib | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-0512 | CALQUENCE | Acalabrutinib | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-0512 | CALQUENCE | Acalabrutinib | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-0512 | CALQUENCE | Acalabrutinib | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-0512 | CALQUENCE | Acalabrutinib | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-0512 | CALQUENCE | Acalabrutinib | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-0512 | CALQUENCE | Acalabrutinib | AstraZeneca Pharmaceuticals LP | NDA | Current |
| 0310-0512 | CALQUENCE | Acalabrutinib | AstraZeneca Pharmaceuticals LP | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 85131 | SUPPL | 2026-02-24 |
| 85102 | SUPPL | 2026-02-23 |
| 80873 | SUPPL | 2025-01-17 |
| 80866 | SUPPL | 2025-01-17 |
| 78726 | SUPPL | 2024-07-02 |
| 78699 | SUPPL | 2024-06-06 |
| 70608 | SUPPL | 2022-03-25 |
| 70605 | SUPPL | 2022-03-25 |
| 61754 | SUPPL | 2020-02-03 |
| 61753 | SUPPL | 2020-02-03 |
| 61035 | SUPPL | 2019-11-22 |
| 61034 | SUPPL | 2019-11-22 |
| 61010 | SUPPL | 2019-11-21 |
| 61009 | SUPPL | 2019-11-21 |
| 50655 | ORIG | 2017-12-12 |
| 50244 | ORIG | 2017-10-31 |
| 50237 | ORIG | 2017-10-31 |