APPLICATION
ANDA088489
TYPE
ANDA
ORIGINAL APPROVAL
1985-01-16
LATEST ACTION
1996-05-30
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
PROCAN SRDiscontinued
PROCAINAMIDE HYDROCHLORIDE 1GM · TABLET, EXTENDED RELEASE · ORAL
Approval history
1996-05-30Labeling · Supplement 16AP
1992-03-26Labeling · Supplement 15AP
1990-11-08Labeling · Supplement 13AP
1989-01-01Labeling · Supplement 5AP
1985-01-16OriginalAP
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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