← FDA DRUG APPROVALS

FDA ANDA · ANDA216833

ACALABRUTINIB

Sponsor: MSN LABORATORIES PRIVATE LTD

APPLICATION
ANDA216833
TYPE
ANDA
DOSAGE FORM
CAPSULE
MARKETING STATUS
None (Tentative Approval)

Products

ACALABRUTINIBNone (Tentative Approval)
ACALABRUTINIB 100MG · CAPSULE

Approval history

2025-05-12UNKNOWN · Original · standardTA
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA enforcement & recalls

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →