← FDA Drug Approvals (Drugs@FDA)
ACALABRUTINIB
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MSN LABORATORIES PRIVATE LTD · Approved 2025-05-12
Drug application
- FDA Application #
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
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown