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FDA NDA · NDA010775

TRILAFON

Sponsor: SCHERING

APPLICATION
NDA010775
TYPE
NDA
ORIGINAL APPROVAL
1957-02-27
LATEST ACTION
2002-05-10
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TRILAFON · ReferenceDiscontinued
PERPHENAZINE 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
TRILAFON · ReferenceDiscontinued
PERPHENAZINE 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
TRILAFON · ReferenceDiscontinued
PERPHENAZINE 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
TRILAFON · ReferenceDiscontinued
PERPHENAZINE 4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2002-05-10Labeling · Supplement 31 · standard — Review ↗AP
2001-10-18Labeling · Supplement 30 · standardAP
2001-03-15Labeling · Supplement 29 · standard — Letter ↗AP
2000-06-01Manufacturing (CMC) · Supplement 26 · standardAP
2000-03-03Manufacturing (CMC) · Supplement 28 · standardAP
1999-04-07Manufacturing (CMC) · Supplement 27 · standardAP
1998-08-21Manufacturing (CMC) · Supplement 25 · standardAP
1995-10-20Manufacturing (CMC) · Supplement 24 · standardAP
1982-03-29Labeling · Supplement 15 · standardAP
1957-02-27Type 1 - New Molecular Entity · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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