# ACALABRUTINIB
> **ANDA216833** · Abbreviated New Drug Application (Generic) · Sponsor: MSN LABORATORIES PRIVATE LTD · Approved 2025-05-12
## Drug
- **FDA Application Number:** ANDA216833
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** ACALABRUTINIB
- **Generic name:** Acalabrutinib
- **Active ingredients:** ACALABRUTINIB
- **Dosage form:** CAPSULE
- **Route:** —
- **Marketing status:** None (Tentative Approval)
- **Sponsor:** MSN LABORATORIES PRIVATE LTD
- **First approval:** 2025-05-12
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=216833)
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