Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 216387
Company: ASTRAZENECA
Company: ASTRAZENECA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CALQUENCE | ACALABRUTINIB MALEATE | EQ 100MG BASE | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 08/03/2022 | ORIG-2 | Approval | Type 3 - New Dosage Form | STANDARD; Orphan |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216387Orig2s000Correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/216387Orig2s000Correctedltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/216387Orig1Orig2s000TOC.cfm | |
| 08/03/2022 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD; Orphan |
Label (PDF)
Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216387Orig1s000Correctedlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/216387Orig1Orig2s000TOC.cfm |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/03/2022 | ORIG-2 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216387Orig2s000Correctedlbl.pdf | |
| 08/03/2022 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/216387Orig1s000Correctedlbl.pdf |