APPLICATION
ANDA089042
TYPE
ANDA
ORIGINAL APPROVAL
1985-10-22
LATEST ACTION
1991-12-16
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
PROCAINAMIDE HYDROCHLORIDEDiscontinued
PROCAINAMIDE HYDROCHLORIDE 750MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
1991-12-16Labeling · Supplement 5AP
1991-08-30Labeling · Supplement 4AP
1991-08-07Manufacturing (CMC) · Supplement 2AP
1989-01-12Labeling · Supplement 1AP
1985-10-22OriginalAP
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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