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 |