APPLICATION
ANDA214222
TYPE
ANDA
ORIGINAL APPROVAL
2021-03-08
LATEST ACTION
2022-01-03
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
2022-01-03Manufacturing (CMC) · Supplement 1 · unknownAP
2021-03-08UNKNOWN · Original · 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.
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