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FDA ANDA · ANDA089026

PROCAINAMIDE HYDROCHLORIDE

Sponsor: WATSON LABS

APPLICATION
ANDA089026
TYPE
ANDA
ORIGINAL APPROVAL
1985-10-22
LATEST ACTION
1998-06-08
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

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

Approval history

1998-06-08Manufacturing (CMC) · Supplement 11AP
1993-05-06Manufacturing (CMC) · Supplement 5AP
1993-05-06Manufacturing (CMC) · Supplement 3AP
1993-05-06Manufacturing (CMC) · Supplement 4AP
1992-02-19Manufacturing (CMC) · Supplement 9AP
1991-12-16Labeling · Supplement 10AP
1991-09-26Labeling · Supplement 8AP
1991-08-07Manufacturing (CMC) · Supplement 6AP
1991-01-28Manufacturing (CMC) · Supplement 7AP
1989-01-12Labeling · Supplement 1AP
1988-08-10Labeling · Supplement 2AP
1985-10-22OriginalAP
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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