CALQUENCE
Active substance: acalabrutinib
CAPSULE, GELATIN COATED · ACALABRUTINIB 100 mg/1
United StatesActive
Marketing holder: AstraZeneca Pharmaceuticals LP
Verified 2026-10-09 · openFDA NDC
Analogues in other countries- Source: openFDA NDC
- Countries with the substance registered: 2
Composition
- ACALABRUTINIB · 100 mg/1
Analogues by country
Products with the same active substance registered in other countries.
| Country | Products |
|---|---|
| EU 1 |
|
Import and control
Control by country
- United Statesprescription only
Source: openFDA NDC · record 01a1208c-94c9-797d-acfc-ac2988e85830,01a12094-2af3-7a6a-9984-3fca116aafc1,01a12096-da0d-71f4-833d-20257b405ad5;count=3 · valid from 2026-10-09 · verified 2026-10-09
Registration
- Registration number
- 0310-0512
- Registration status
- Active
- Dispensing
- Prescription only
- Route
- ORAL
Sources
- product · openFDA NDC · 0310-0512 · Verified 2026-10-09 · open in source
- registration_status · openFDA NDC · 0310-0512 · Verified 2026-10-09 · open in source
- ingredients.0 · openFDA NDC · 0310-0512 · Verified 2026-10-09 · open in source