APPLICATION
NDA011683
TYPE
NDA
ORIGINAL APPROVAL
1959-03-09
LATEST ACTION
1993-02-23
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
THIOTEPADiscontinued
THIOTEPA 15MG/VIAL · INJECTABLE · INJECTION
Approval history
1993-02-23Labeling · Supplement 23AP
1990-12-18Manufacturing (CMC) · Supplement 21 · priorityAP
1986-10-17Labeling · Supplement 16AP
1986-02-14Manufacturing (CMC) · Supplement 15 · priorityAP
1981-03-24Manufacturing (CMC) · Supplement 12 · priorityAP
1978-09-21Manufacturing (CMC) · Supplement 10 · priorityAP
1978-09-16Manufacturing (CMC) · Supplement 11 · priorityAP
1978-04-10REMS · Supplement 9 · priorityAP
1975-09-15Manufacturing (CMC) · Supplement 7 · priorityAP
1959-03-09Type 1 - New Molecular Entity · Original · priorityAP
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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