Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 210259
Company: ASTRAZENECA
Company: ASTRAZENECA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CALQUENCE | ACALABRUTINIB | 100MG | CAPSULE;ORAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/31/2017 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/210259s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/210259Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/210259Orig1s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/16/2025 | SUPPL-11 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210259s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/210259Orig1s011;216387Orig1s005ltr.pdf | |
06/05/2024 | SUPPL-10 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210259s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/210259Orig1s010ltr.pdf | |
03/24/2022 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210259s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/210259Orig1s009ltr.pdf | |
11/21/2019 | SUPPL-7 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210259s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210259Orig1s006, s007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210259Orig1s006, s007.pdf | |
11/21/2019 | SUPPL-6 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210259s006s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210259Orig1s006, s007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/210259Orig1s006, s007.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/16/2025 | SUPPL-11 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/210259s011lbl.pdf | |
06/05/2024 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210259s010lbl.pdf | |
06/05/2024 | SUPPL-10 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/210259s010lbl.pdf | |
03/24/2022 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210259s009lbl.pdf | |
11/21/2019 | SUPPL-7 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210259s006s007lbl.pdf | |
11/21/2019 | SUPPL-6 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210259s006s007lbl.pdf | |
10/31/2017 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/210259s000lbl.pdf |