NDC 0310-3512

CALQUENCE

Acalabrutinib

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 ID0310-3512_b1409184-3267-4d8c-8f17-4e01f69828b1
NDC0310-3512
Product TypeHuman Prescription Drug
Proprietary NameCALQUENCE
Generic NameAcalabrutinib
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2022-08-04
Marketing CategoryNDA /
Application NumberNDA216387
Labeler NameAstraZeneca Pharmaceuticals LP
Substance NameACALABRUTINIB
Active Ingredient Strength100 mg/1
Pharm ClassesKinase Inhibitor [EPC], Tyrosine Kinase Inhibitors [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0310-3512-60

60 TABLET, FILM COATED in 1 BOTTLE (0310-3512-60)
Marketing Start Date2022-08-04
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "CALQUENCE" or generic name "Acalabrutinib"

NDCBrand NameGeneric Name
0310-0512CALQUENCEAcalabrutinib
0310-3512CALQUENCEacalabrutinib

Trademark Results [CALQUENCE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CALQUENCE
CALQUENCE
87072359 5221345 Live/Registered
AstraZeneca AB
2016-06-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.