← FDA DRUG APPROVALS

FDA ANDA · ANDA084403

PROCAINAMIDE HYDROCHLORIDE

Sponsor: WATSON LABS

APPLICATION
ANDA084403
TYPE
ANDA
ORIGINAL APPROVAL
1977-06-03
LATEST ACTION
1998-07-29
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

PROCAINAMIDE HYDROCHLORIDEDiscontinued
PROCAINAMIDE HYDROCHLORIDE 375MG · CAPSULE · ORAL

Approval history

1998-07-29Labeling · Supplement 42AP
1992-02-24Labeling · Supplement 41AP
1991-08-07Manufacturing (CMC) · Supplement 39AP
1991-01-28Manufacturing (CMC) · Supplement 40AP
1990-06-29Manufacturing (CMC) · Supplement 38AP
1988-11-01Labeling · Supplement 37AP
1988-03-07Manufacturing (CMC) · Supplement 35AP
1988-03-07Manufacturing (CMC) · Supplement 36AP
1988-03-07Manufacturing (CMC) · Supplement 34AP
1985-12-18Manufacturing (CMC) · Supplement 29AP
1985-12-18Manufacturing (CMC) · Supplement 31AP
1985-12-18Manufacturing (CMC) · Supplement 30AP
1985-07-19Manufacturing (CMC) · Supplement 26AP
1985-05-28Manufacturing (CMC) · Supplement 27AP
1985-05-28Manufacturing (CMC) · Supplement 28AP
1983-12-09Manufacturing (CMC) · Supplement 25AP
1983-01-21Manufacturing (CMC) · Supplement 24AP
1977-06-03OriginalAP
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 →