APPLICATION
NDA012754
TYPE
NDA
ORIGINAL APPROVAL
1961-07-18
LATEST ACTION
2001-05-10
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
TORECANDiscontinued
THIETHYLPERAZINE MALATE 5MG/ML · INJECTABLE · INJECTION
Approval history
2001-05-10Manufacturing (CMC) · Supplement 35 · standardAP
1997-08-06Labeling · Supplement 28AP
1997-08-06Labeling · Supplement 34 · standardAP
1997-08-06Labeling · Supplement 25AP
1996-12-17Manufacturing (CMC) · Supplement 33 · standardAP
1995-09-19Manufacturing (CMC) · Supplement 32 · standardAP
1993-09-14Manufacturing (CMC) · Supplement 27 · standardAP
1993-09-02Manufacturing (CMC) · Supplement 29 · standardAP
1993-07-08Manufacturing (CMC) · Supplement 31 · standardAP
1989-09-22Manufacturing (CMC) · Supplement 24 · standardAP
1989-08-08Labeling · Supplement 23AP
1989-02-28Manufacturing (CMC) · Supplement 21 · standardAP
1988-04-20Manufacturing (CMC) · Supplement 16 · standardAP
1961-07-18Type 3 - New Dosage Form · 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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