← FDA DRUG APPROVALS

FDA NDA · NDA009149

THORAZINE

Sponsor: GLAXOSMITHKLINE

APPLICATION
NDA009149
TYPE
NDA
ORIGINAL APPROVAL
1957-11-20
LATEST ACTION
1998-04-22
ROUTE
ORAL, RECTAL, INJECTION
DOSAGE FORM
TABLET, CONCENTRATE, SUPPOSITORY, INJECTABLE, SYRUP
MARKETING STATUS
Discontinued

Products

THORAZINEDiscontinued
CHLORPROMAZINE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
THORAZINE · ReferenceDiscontinued
CHLORPROMAZINE HYDROCHLORIDE 100MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CONCENTRATE · ORAL
THORAZINE · ReferenceDiscontinued
CHLORPROMAZINE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SUPPOSITORY · RECTAL
THORAZINEDiscontinued
CHLORPROMAZINE HYDROCHLORIDE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
THORAZINEDiscontinued
CHLORPROMAZINE HYDROCHLORIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
THORAZINE · ReferenceDiscontinued
CHLORPROMAZINE HYDROCHLORIDE 25MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
THORAZINEDiscontinued
CHLORPROMAZINE HYDROCHLORIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
THORAZINE · ReferenceDiscontinued
CHLORPROMAZINE HYDROCHLORIDE 30MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CONCENTRATE · ORAL
THORAZINE · ReferenceDiscontinued
CHLORPROMAZINE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SUPPOSITORY · RECTAL
THORAZINE · ReferenceDiscontinued
CHLORPROMAZINE HYDROCHLORIDE 10MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SYRUP · ORAL
THORAZINEDiscontinued
CHLORPROMAZINE HYDROCHLORIDE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

1998-04-22Labeling · Supplement 165 · priorityAP
1996-09-20Manufacturing (CMC) · Supplement 178 · priorityAP
1994-08-19Manufacturing (CMC) · Supplement 151 · priorityAP
1992-02-14Manufacturing (CMC) · Supplement 173 · priorityAP
1957-11-20Type 1 - New Molecular Entity · Original · priorityAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →