APPLICATION
ANDA089029
TYPE
ANDA
ORIGINAL APPROVAL
1986-04-17
LATEST ACTION
2000-04-03
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
PROCAINAMIDE HYDROCHLORIDEDiscontinued
PROCAINAMIDE HYDROCHLORIDE 100MG/ML · INJECTABLE · INJECTION
Approval history
2000-04-03Manufacturing (CMC) · Supplement 9AP
1998-06-12Labeling · Supplement 8AP
1991-12-09Labeling · Supplement 6AP
1988-11-07Labeling · Supplement 5AP
1988-03-04Manufacturing (CMC) · Supplement 4AP
1986-11-03Manufacturing (CMC) · Supplement 2AP
1986-09-05Manufacturing (CMC) · Supplement 1AP
1986-04-17OriginalAP
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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