APPLICATION
ANDA089069
TYPE
ANDA
ORIGINAL APPROVAL
1986-02-12
LATEST ACTION
1999-05-05
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
PROCAINAMIDE HYDROCHLORIDEPrescription
PROCAINAMIDE HYDROCHLORIDE 100MG/ML · INJECTABLE · INJECTION
Approval history
1999-05-05Labeling · Supplement 16AP
1998-12-21Labeling · Supplement 10AP
1998-06-08Manufacturing (CMC) · Supplement 14AP
1998-06-08Manufacturing (CMC) · Supplement 12AP
1998-05-05Manufacturing (CMC) · Supplement 11AP
1998-02-12Labeling · Supplement 13AP
1994-08-24Manufacturing (CMC) · Supplement 8AP
1993-12-21Manufacturing (CMC) · Supplement 7AP
1991-11-22Labeling · Supplement 6AP
1991-08-13Labeling · Supplement 5AP
1991-01-28Labeling · 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.
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