APPLICATION
ANDA075547
TYPE
ANDA
ORIGINAL APPROVAL
2001-04-02
LATEST ACTION
2015-07-08
ROUTE
INTRACAVITARY, INTRAVENOUS, INTRAVESICAL, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
THIOTEPAPrescription
THIOTEPA 15MG/VIAL · INJECTABLE · INJECTION
Approval history
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.