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FDA ANDA · ANDA089369

PROCAINAMIDE HYDROCHLORIDE

Sponsor: ANI PHARMS

APPLICATION
ANDA089369
TYPE
ANDA
ORIGINAL APPROVAL
1987-08-14
LATEST ACTION
2001-05-09
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

PROCAINAMIDE HYDROCHLORIDEDiscontinued
PROCAINAMIDE HYDROCHLORIDE 750MG · TABLET, EXTENDED RELEASE · ORAL
PROCAINAMIDE HYDROCHLORIDEDiscontinued
PROCAINAMIDE HYDROCHLORIDE 250MG · TABLET, EXTENDED RELEASE · ORAL
PROCAINAMIDE HYDROCHLORIDEDiscontinued
PROCAINAMIDE HYDROCHLORIDE 500MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2001-05-09Manufacturing (CMC) · Supplement 9AP
1995-03-30Manufacturing (CMC) · Supplement 8AP
1992-01-07Labeling · Supplement 7AP
1989-01-23Labeling · Supplement 6AP
1988-11-29Labeling · Supplement 5AP
1987-08-14OriginalAP
VIEW ON DRUGS@FDA ↗

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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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