APPLICATION
ANDA089070
TYPE
ANDA
ORIGINAL APPROVAL
1986-02-12
LATEST ACTION
1999-05-05
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
PROCAINAMIDE HYDROCHLORIDEDiscontinued
PROCAINAMIDE HYDROCHLORIDE 500MG/ML · INJECTABLE · INJECTION
Approval history
1999-05-05Labeling · Supplement 12AP
1998-12-21Labeling · Supplement 9AP
1998-05-05Manufacturing (CMC) · Supplement 10AP
1998-02-12Labeling · Supplement 11AP
1994-08-24Manufacturing (CMC) · Supplement 7AP
1993-12-22Manufacturing (CMC) · Supplement 6AP
1991-11-22Labeling · Supplement 5AP
1990-08-16Labeling · Supplement 4AP
1988-11-23Labeling · Supplement 2AP
1988-08-12Labeling · Supplement 3AP
1986-02-12OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.