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FDA NDA · NDA020058

THIOPLEX

Sponsor: IMMUNEX

APPLICATION
NDA020058
TYPE
NDA
ORIGINAL APPROVAL
1994-12-22
LATEST ACTION
2000-10-12
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

THIOPLEX · ReferenceDiscontinued
THIOTEPA 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2000-10-12Labeling · Supplement 9 · standard — Review ↗AP
2000-10-12Manufacturing (CMC) · Supplement 10 · standard — Review ↗AP
2000-05-16Manufacturing (CMC) · Supplement 6 · standardAP
2000-03-02Manufacturing (CMC) · Supplement 8 · standardAP
1999-04-22Manufacturing (CMC) · Supplement 5 · standardAP
1999-02-08Manufacturing (CMC) · Supplement 7 · standardAP
1997-11-26Labeling · Supplement 4 · standardAP
1997-09-26Manufacturing (CMC) · Supplement 2 · standardAP
1997-09-26Manufacturing (CMC) · Supplement 3 · standardAP
1996-05-20Manufacturing (CMC) · Supplement 1 · standardAP
1994-12-22Type 3 - New Dosage Form · Original · standardAP
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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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