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FDA ANDA · ANDA040111

PROCAINAMIDE HYDROCHLORIDE

Sponsor: ANI PHARMS

APPLICATION
ANDA040111
TYPE
ANDA
ORIGINAL APPROVAL
1996-12-13
LATEST ACTION
2002-10-09
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

PROCAINAMIDE HYDROCHLORIDEDiscontinued
PROCAINAMIDE HYDROCHLORIDE 1GM · TABLET, EXTENDED RELEASE · ORAL

Approval history

2002-10-09Manufacturing (CMC) · Supplement 4AP
2002-10-09Manufacturing (CMC) · Supplement 3AP
2002-03-13Labeling · Supplement 6AP
2002-01-04Labeling · Supplement 5AP
2001-04-02Manufacturing (CMC) · Supplement 2AP
1999-03-23Manufacturing (CMC) · Supplement 1AP
1996-12-13OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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