APPLICATION
ANDA088636
TYPE
ANDA
ORIGINAL APPROVAL
1984-07-31
LATEST ACTION
2019-11-13
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
PROCAINAMIDE HYDROCHLORIDEPrescription
PROCAINAMIDE HYDROCHLORIDE 100MG/ML · INJECTABLE · INJECTION
Approval history
2019-11-13Labeling · Supplement 15 · standardAP
2015-04-13Manufacturing (CMC) · Supplement 14AP
1999-09-22Labeling · Supplement 13AP
1998-01-14Manufacturing (CMC) · Supplement 10AP
1995-09-19Manufacturing (CMC) · Supplement 12AP
1994-06-17Manufacturing (CMC) · Supplement 11AP
1993-10-29Manufacturing (CMC) · Supplement 9AP
1992-11-02Labeling · Supplement 8AP
1992-03-13Labeling · Supplement 7AP
1992-02-13Labeling · Supplement 6AP
1991-04-26Labeling · Supplement 5AP
1990-01-05Labeling · Supplement 4AP
1987-09-10Manufacturing (CMC) · Supplement 3AP
1987-01-29Manufacturing (CMC) · Supplement 1AP
1984-07-31OriginalAP
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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