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FDA NDA · NDA011213

TRILAFON

Sponsor: SCHERING

APPLICATION
NDA011213
TYPE
NDA
ORIGINAL APPROVAL
1958-01-29
LATEST ACTION
2007-12-07
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

TRILAFONDiscontinued
PERPHENAZINE 5MG/ML · INJECTABLE · INJECTION

Approval history

2007-12-07Labeling · Supplement 6AP
2007-12-07Labeling · Supplement 4AP
2007-12-07Labeling · Supplement 11AP
2007-12-07Labeling · Supplement 9AP
2007-12-07Labeling · Supplement 7AP
2007-12-07Labeling · Supplement 14AP
2007-12-07Labeling · Supplement 5AP
2007-12-07Labeling · Supplement 3AP
2002-05-10Labeling · Supplement 24 · standardReviewAP
2001-10-18Labeling · Supplement 22 · standardAP
2001-05-31Manufacturing (CMC) · Supplement 23 · standardAP
2001-03-15Labeling · Supplement 21 · standardReviewAP
1999-09-10Manufacturing (CMC) · Supplement 20 · standardAP
1999-07-26Manufacturing (CMC) · Supplement 19 · standardAP
1999-01-27Manufacturing (CMC) · Supplement 18 · standardAP
1997-08-07Manufacturing (CMC) · Supplement 17 · standardAP
1996-11-22Manufacturing (CMC) · Supplement 16 · standardAP
1982-03-29Labeling · Supplement 8AP
1958-01-29Type 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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