CALQUENCE is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Acalabrutinib.
| Product ID | 0310-3512_b1409184-3267-4d8c-8f17-4e01f69828b1 |
| NDC | 0310-3512 |
| Product Type | Human Prescription Drug |
| Proprietary Name | CALQUENCE |
| Generic Name | Acalabrutinib |
| Dosage Form | Tablet, Film Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2022-08-04 |
| Marketing Category | NDA / |
| Application Number | NDA216387 |
| Labeler Name | AstraZeneca Pharmaceuticals LP |
| Substance Name | ACALABRUTINIB |
| Active Ingredient Strength | 100 mg/1 |
| Pharm Classes | Kinase Inhibitor [EPC], Tyrosine Kinase Inhibitors [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2023-12-31 |
| Marketing Start Date | 2022-08-04 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0310-0512 | CALQUENCE | Acalabrutinib |
| 0310-3512 | CALQUENCE | acalabrutinib |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CALQUENCE 87072359 5221345 Live/Registered |
AstraZeneca AB 2016-06-15 |