APPLICATION
ANDA088958
TYPE
ANDA
ORIGINAL APPROVAL
1985-12-02
LATEST ACTION
1994-05-11
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
PROCAINAMIDE HYDROCHLORIDEDiscontinued
PROCAINAMIDE HYDROCHLORIDE 250MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
1994-05-11Manufacturing (CMC) · Supplement 13AP
1992-09-03Manufacturing (CMC) · Supplement 9AP
1992-09-03Manufacturing (CMC) · Supplement 12AP
1992-03-04Labeling · Supplement 11AP
1989-02-17Labeling · Supplement 6AP
1989-01-05Manufacturing (CMC) · Supplement 8AP
1988-05-02Manufacturing (CMC) · Supplement 7AP
1986-06-05Manufacturing (CMC) · Supplement 4AP
1986-02-26Manufacturing (CMC) · Supplement 3AP
1986-02-26Manufacturing (CMC) · Supplement 1AP
1985-12-02OriginalAP
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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