APPLICATION
ANDA075698
TYPE
ANDA
ORIGINAL APPROVAL
2001-09-20
LATEST ACTION
2002-12-05
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
THIOTEPADiscontinued
THIOTEPA 15MG/VIAL · INJECTABLE · INJECTION
Approval history
2002-12-05Manufacturing (CMC) · Supplement 4AP
2002-10-01Manufacturing (CMC) · Supplement 3AP
2002-09-18Manufacturing (CMC) · Supplement 2AP
2002-07-11Manufacturing (CMC) · Supplement 1AP
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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