← FDA DRUG APPROVALS

FDA ANDA · ANDA215893

PONATINIB HYDROCHLORIDE

Sponsor: APOTEX

APPLICATION
ANDA215893
TYPE
ANDA
ORIGINAL APPROVAL
2023-07-14
LATEST ACTION
2023-07-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

PONATINIB HYDROCHLORIDEDiscontinued
PONATINIB HYDROCHLORIDE EQ 15MG BASE · TABLET · ORAL
PONATINIB HYDROCHLORIDEDiscontinued
PONATINIB HYDROCHLORIDE EQ 45MG BASE · TABLET · ORAL

Approval history

2024-11-27Manufacturing (CMC) · Supplement 3 · unknownTA
2023-07-14UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA 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 →