APPLICATION
ANDA089370
TYPE
ANDA
ORIGINAL APPROVAL
1987-01-09
LATEST ACTION
1992-01-07
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
PROCAINAMIDE HYDROCHLORIDEDiscontinued
PROCAINAMIDE HYDROCHLORIDE 500MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
1992-01-07Labeling · Supplement 9AP
1989-01-23Labeling · Supplement 7AP
1988-11-29Labeling · Supplement 6AP
1987-01-09OriginalAP
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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