APPLICATION
ANDA203554
TYPE
ANDA
ORIGINAL APPROVAL
2014-09-19
LATEST ACTION
2024-08-22
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
PENTOSTATINDiscontinued
PENTOSTATIN 10MG/VIAL · INJECTABLE · INJECTION
Approval history
2024-08-22Labeling · Supplement 2 · standardAP
2014-09-19UNKNOWN · OriginalAP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.