← FDA DRUG APPROVALS

FDA NDA · NDA010348

SPARINE

Sponsor: WYETH AYERST

APPLICATION
NDA010348
TYPE
NDA
ORIGINAL APPROVAL
1957-04-08
LATEST ACTION
1957-04-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

SPARINEDiscontinued
PROMAZINE HYDROCHLORIDE 100MG · TABLET · ORAL
SPARINEDiscontinued
PROMAZINE HYDROCHLORIDE 25MG · TABLET · ORAL
SPARINEDiscontinued
PROMAZINE HYDROCHLORIDE 10MG · TABLET · ORAL
SPARINEDiscontinued
PROMAZINE HYDROCHLORIDE 200MG · TABLET · ORAL
SPARINEDiscontinued
PROMAZINE HYDROCHLORIDE 50MG · TABLET · ORAL

Approval history

1957-04-08Type 3 - New Dosage Form · Original · standardAP
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 →