APPLICATION
ANDA213049
TYPE
ANDA
ORIGINAL APPROVAL
2020-03-04
LATEST ACTION
2024-05-30
ROUTE
INTRACAVITARY, INTRAVENOUS, INTRAVESICAL, INTRACAVITARY, INTRAVENOUS, INTRAVESICAL
DOSAGE FORM
POWDER
MARKETING STATUS
Prescription
Products
THIOTEPAPrescription
THIOTEPA 100MG/VIAL · POWDER · INTRACAVITARY, INTRAVENOUS, INTRAVESICAL
THIOTEPAPrescription
THIOTEPA 15MG/VIAL · POWDER · INTRACAVITARY, INTRAVENOUS, INTRAVESICAL
Approval history
2024-05-30Labeling · Supplement 2 · standardAP
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.