APPLICATION
ANDA089371
TYPE
ANDA
ORIGINAL APPROVAL
1987-08-14
LATEST ACTION
1992-01-07
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
PROCAINAMIDE HYDROCHLORIDEDiscontinued
PROCAINAMIDE HYDROCHLORIDE 750MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
1992-01-07Labeling · Supplement 3AP
1989-01-23Labeling · Supplement 2AP
1988-11-29Labeling · Supplement 1AP
1987-08-14OriginalAP
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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