APPLICATION
ANDA087510
TYPE
ANDA
ORIGINAL APPROVAL
1995-09-22
LATEST ACTION
1996-05-30
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
PROCAN SR · ReferenceDiscontinued
PROCAINAMIDE HYDROCHLORIDE 750MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
1996-05-30Labeling · Supplement 29AP
1995-09-22OriginalAP
1993-06-23Labeling · Supplement 26AP
1992-03-03Labeling · Supplement 25AP
1991-06-06Labeling · Supplement 24AP
1989-01-27Labeling · Supplement 20AP
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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