← FDA Drug Approvals (Drugs@FDA)
ACALABRUTINIB
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALEMBIC PHARMS LTD · Approved 2023-01-18
Drug application
- FDA Application #
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
- Authoritative
- Drugs@FDA application overview
- Machine
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