# ACALABRUTINIB
> **ANDA216775** · Abbreviated New Drug Application (Generic) · Sponsor: ALEMBIC PHARMS LTD · Approved 2023-01-18
## Drug
- **FDA Application Number:** ANDA216775
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** ACALABRUTINIB
- **Generic name:** Acalabrutinib
- **Active ingredients:** ACALABRUTINIB
- **Dosage form:** CAPSULE
- **Route:** ORAL
- **Marketing status:** None (Tentative Approval)
- **Sponsor:** ALEMBIC PHARMS LTD
- **First approval:** 2023-01-18
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216775)
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