← FDA DRUG APPROVALS

FDA ANDA · ANDA083640

QUINIDINE SULFATE

Sponsor: CYCLE

APPLICATION
ANDA083640
TYPE
ANDA
ORIGINAL APPROVAL
1975-07-15
LATEST ACTION
1996-08-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

QUINIDINE SULFATEDiscontinued
QUINIDINE SULFATE 200MG · TABLET · ORAL

Approval history

1996-08-28Manufacturing (CMC) · Supplement 28AP
1996-07-15Labeling · Supplement 29AP
1991-05-09Labeling · Supplement 27AP
1991-05-09Labeling · Supplement 26AP
1990-11-30Manufacturing (CMC) · Supplement 25AP
1990-11-30Manufacturing (CMC) · Supplement 22AP
1989-02-07Manufacturing (CMC) · Supplement 21AP
1989-02-07Manufacturing (CMC) · Supplement 20AP
1988-05-17Labeling · Supplement 19AP
1984-01-25Manufacturing (CMC) · Supplement 17AP
1982-08-30Manufacturing (CMC) · Supplement 15AP
1975-07-15OriginalAP
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.

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 →