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FDA NDA · NDA020545

PROCANBID

Sponsor: KING PHARMS

APPLICATION
NDA020545
TYPE
NDA
ORIGINAL APPROVAL
1996-01-31
LATEST ACTION
2002-07-11
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

PROCANBIDDiscontinued
PROCAINAMIDE HYDROCHLORIDE 1GM · TABLET, EXTENDED RELEASE · ORAL
PROCANBIDDiscontinued
PROCAINAMIDE HYDROCHLORIDE 500MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2002-07-11Manufacturing (CMC) · Supplement 7 · standard — Review ↗AP
2000-07-11Labeling · Supplement 4 · standardAP
1999-03-11Manufacturing (CMC) · Supplement 5 · standardAP
1998-02-09Manufacturing (CMC) · Supplement 3 · standardAP
1997-08-07Manufacturing (CMC) · Supplement 2 · standardAP
1996-12-30Labeling · Supplement 1 · standardAP
1996-01-31Type 3 - New Dosage Form · Original · standard — Review ↗AP
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.

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