APPLICATION
ANDA089537
TYPE
ANDA
ORIGINAL APPROVAL
2004-07-29
LATEST ACTION
2004-07-29
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
PROCAINAMIDE HYDROCHLORIDEDiscontinued
PROCAINAMIDE HYDROCHLORIDE 500MG/ML · INJECTABLE · INJECTION
Approval history
2004-07-29OriginalAP
2001-02-14Manufacturing (CMC) · Supplement 7AP
1995-12-22Manufacturing (CMC) · Supplement 6AP
1992-06-26Labeling · Supplement 4AP
1990-11-30Manufacturing (CMC) · Supplement 3AP
1989-07-06Manufacturing (CMC) · Supplement 2AP
1989-02-03Labeling · Supplement 1AP
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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