Application 216387
- Type
- NDA
- Sponsor
- ASTRAZENECA UK LTD
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CALQUENCE | ACALABRUTINIB | TABLET, FILM COATED | 100MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0310-3512 | CALQUENCE | acalabrutinib | AstraZeneca Pharmaceuticals LP | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85132 | SUPPL | 2026-02-24 |
| 85103 | SUPPL | 2026-02-23 |
| 80874 | SUPPL | 2025-01-17 |
| 80865 | SUPPL | 2025-01-17 |
| 78733 | SUPPL | 2024-07-02 |
| 78700 | SUPPL | 2024-06-06 |
| 74314 | ORIG | 2023-05-19 |
| 74313 | ORIG | 2023-05-19 |
| 71734 | ORIG | 2022-08-05 |
| 71733 | ORIG | 2022-08-05 |
| 71724 | ORIG | 2022-08-05 |