← FDA DRUG APPROVALS

FDA ANDA · ANDA216236

NERATINIB MALEATE

Sponsor: SANDOZ INC

APPLICATION
ANDA216236
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)

Products

NERATINIB MALEATENone (Tentative Approval)
NERATINIB MALEATE 40MG · TABLET · ORAL

Approval history

2022-07-05UNKNOWN · Original · standardLetterTA
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 →