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FDA NDA · NDA011552

STELAZINE

Sponsor: GLAXOSMITHKLINE

APPLICATION
NDA011552
TYPE
NDA
ORIGINAL APPROVAL
1959-04-16
LATEST ACTION
2001-10-18
ROUTE
INJECTION, ORAL
DOSAGE FORM
INJECTABLE, TABLET, CONCENTRATE
MARKETING STATUS
Discontinued

Products

STELAZINE · ReferenceDiscontinued
TRIFLUOPERAZINE HYDROCHLORIDE EQ 2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
STELAZINE · ReferenceDiscontinued
TRIFLUOPERAZINE HYDROCHLORIDE EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
STELAZINE · ReferenceDiscontinued
TRIFLUOPERAZINE HYDROCHLORIDE EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
STELAZINE · ReferenceDiscontinued
TRIFLUOPERAZINE HYDROCHLORIDE EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CONCENTRATE · ORAL
STELAZINE · ReferenceDiscontinued
TRIFLUOPERAZINE HYDROCHLORIDE EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
STELAZINE · ReferenceDiscontinued
TRIFLUOPERAZINE HYDROCHLORIDE EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2001-10-18Manufacturing (CMC) · Supplement 113 · standardAP
2001-04-03Labeling · Supplement 112 · standard — Review ↗AP
1997-10-14Manufacturing (CMC) · Supplement 111 · standardAP
1996-08-14Manufacturing (CMC) · Supplement 110 · standardAP
1979-05-03Labeling · Supplement 71 · standardAP
1959-04-16Type 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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