CALQUENCE
NDA 216387 · New Drug Application (NDA) Prescription
ACALABRUTINIB MALEATE
- Sponsor (Drugs@FDA)
- ASTRAZENECA Company: ASTRAZENECA PLC (AZN)
- First approved
- Latest action
Drugs on HealthTrade
Drugs whose FDA actions or confirmed applications cite this number. A drug listed from this record shows “Not yet reviewed” on its page until an editor checks it.
Products
| Product | Name and ingredient | Form and strength | Marketing status | TE code | Reference | Orange Book |
|---|---|---|---|---|---|---|
| 001 | CALQUENCE ACALABRUTINIB MALEATE | TABLET;ORAL EQ 100MG BASE | Prescription | – | Reference listed drug, Reference standard | RXApproved |
Submissions
| Submission | Status | Status date | Review | Class | Documents |
|---|---|---|---|---|---|
| Supplement 6 | Approved | standard | Efficacy | Letter for Supplement 6 (opens in a new tab)Label for Supplement 6 (opens in a new tab) | |
| Supplement 5 | Approved | priority | Efficacy | Letter for Supplement 5 (opens in a new tab)Label for Supplement 5 (opens in a new tab) | |
| Supplement 4 | Approved | 901 required | Labeling | Letter for Supplement 4 (opens in a new tab)Label for Supplement 4 (opens in a new tab) | |
| Original 1 | Approved | standard | Type 3 - New Dosage Form | Label for Original 1 (opens in a new tab) | |
| Original 2 | Approved | standard | Type 3 - New Dosage Form | Letter for Original 2 (opens in a new tab)Label for Original 2 (opens in a new tab) |
Orange Book patents
29 patents listed, as the Orange Book prints them.
| Patent | Expires | Claims | Use code | Submitted |
|---|---|---|---|---|
| 7459554Product 001 | Drug substance | – | ||
| 9290504Product 001 | Drug substance, Drug product | – | ||
| 9758524Product 001 | Method of use | U-2145 | ||
| 9758524Product 001 | Method of use | U-4108 | ||
| 10239883Product 001 | Method of use | U-2666 | ||
| 10239883Product 001 | Method of use | U-2668 | ||
| 10272083Product 001 | Method of use | U-2519 | ||
| 10272083Product 001 | Method of use | U-2682 | ||
| 10272083Product 001 | Method of use | U-2683 | ||
| 10272083Product 001 | Method of use | U-2684 | ||
| 10272083Product 001 | Method of use | U-2685 | ||
| 10272083Product 001 | Method of use | U-2686 | ||
| 10272083Product 001 | Method of use | U-2687 | ||
| 10272083Product 001 | Method of use | U-4109 | ||
| 11771696Product 001 | Method of use | U-3710 | ||
| 11166951Product 001 | Method of use | U-4426 | ||
| 11166951Product 001 | Method of use | U-4427 | ||
| 11166951Product 001 | Method of use | U-4428 | ||
| 11166951Product 001 | Method of use | U-4429 | ||
| 11166951Product 001 | Method of use | U-4430 | ||
| 11166951Product 001 | Method of use | U-4431 | ||
| 11059829Product 001 | Drug substance, Drug product | U-2145 | ||
| 11059829Product 001 | Drug substance, Drug product | U-2666 | ||
| 11059829Product 001 | Drug substance, Drug product | U-2667 | ||
| 11059829Product 001 | Drug substance, Drug product | U-2668 | ||
| 11059829Product 001 | Drug substance, Drug product | U-2669 | ||
| 11059829Product 001 | Drug substance, Drug product | U-2670 | ||
| 11059829Product 001 | Drug substance, Drug product | U-2671 | ||
| 11059829Product 001 | Drug substance, Drug product | U-4108 |
Orange Book exclusivities
| Code | Product | Expires |
|---|---|---|
| I-960 | 001 | |
| D-200 | 001 |
Codes as the Orange Book prints them; its preface explains each code.
Prescription labels
No human prescription label in openFDA cites this application.
NDC products
2 products in the NDC directory with this application number.
| Product NDC | Name | Labeler | Form and route | Category | Marketing dates |
|---|---|---|---|---|---|
| 0310-3512 in openFDA (opens in a new tab) | CALQUENCE acalabrutinib | AstraZeneca Pharmaceuticals LP | TABLET, FILM COATED ORAL | NDA | From |
| 0310-4513 in openFDA (opens in a new tab) | CALQUENCE acalabrutinib | AstraZeneca Pharmaceuticals LP | TABLET, FILM COATED ORAL | NDA | From |
FDA recalls load here.
FDA drug shortages load here.
Sources
- Drugs@FDA (opens in a new tab)Licence: public-domain. Drugs@FDA download 2026-10-25.
- Orange Book (opens in a new tab)Licence: public-domain. Orange Book download 2026-10-25.
- openFDA NDC directory (opens in a new tab)Licence: cc0. openFDA NDC download 2026-10-25.
Data provided by the U.S. Food and Drug Administration. Showing it here is not an FDA endorsement. openFDA asks: “Do not rely on openFDA to make decisions regarding medical care.”
Patent and exclusivity dates are as FDA lists them and can change. Nothing on this page is medical or investment advice.