APPLICATION
ANDA085167
TYPE
ANDA
ORIGINAL APPROVAL
1980-07-17
LATEST ACTION
1991-12-09
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
PROCAINAMIDE HYDROCHLORIDEDiscontinued
PROCAINAMIDE HYDROCHLORIDE 250MG · CAPSULE · ORAL
Approval history
1991-12-09Labeling · Supplement 23AP
1991-04-26Labeling · Supplement 22AP
1988-11-29Labeling · Supplement 20AP
1988-08-12Labeling · Supplement 18AP
1980-07-17OriginalAP
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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