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FDA NDA · NDA012753

TORECAN

Sponsor: NOVARTIS

APPLICATION
NDA012753
TYPE
NDA
ORIGINAL APPROVAL
1961-07-18
LATEST ACTION
2001-12-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TORECANDiscontinued
THIETHYLPERAZINE MALEATE 10MG · TABLET · ORAL

Approval history

2001-12-03Manufacturing (CMC) · Supplement 68 · standardAP
2001-07-19Manufacturing (CMC) · Supplement 67 · standardAP
2001-05-09Manufacturing (CMC) · Supplement 66 · standardAP
2000-05-15Manufacturing (CMC) · Supplement 65 · standardAP
1997-08-06Labeling · Supplement 57AP
1997-08-06Labeling · Supplement 51AP
1997-08-06Labeling · Supplement 64 · standardAP
1996-12-02Manufacturing (CMC) · Supplement 63 · standardAP
1995-12-07Manufacturing (CMC) · Supplement 62 · standardAP
1995-10-17Manufacturing (CMC) · Supplement 61 · standardAP
1995-02-27Manufacturing (CMC) · Supplement 60 · standardAP
1994-02-28Manufacturing (CMC) · Supplement 54 · standardAP
1993-09-14Manufacturing (CMC) · Supplement 56 · standardAP
1993-07-07Manufacturing (CMC) · Supplement 59 · standardAP
1990-11-30Manufacturing (CMC) · Supplement 55 · standardAP
1990-03-14Manufacturing (CMC) · Supplement 52 · standardAP
1990-02-23Manufacturing (CMC) · Supplement 47 · standardAP
1990-02-23Manufacturing (CMC) · Supplement 50 · standardAP
1989-08-08Labeling · Supplement 49AP
1989-08-08Manufacturing (CMC) · Supplement 48 · standardAP
1988-09-12Manufacturing (CMC) · Supplement 46 · standardAP
1986-09-26Manufacturing (CMC) · Supplement 43 · standardAP
1986-07-17Manufacturing (CMC) · Supplement 41 · standardAP
1985-12-31Manufacturing (CMC) · Supplement 42 · standardAP
1984-04-16Manufacturing (CMC) · Supplement 40 · standardAP
1976-05-06Manufacturing (CMC) · Supplement 25 · standardAP
1961-07-18Type 1 - New Molecular Entity · 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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