APPLICATION
ANDA087759
TYPE
ANDA
ORIGINAL APPROVAL
1982-10-01
LATEST ACTION
1992-05-01
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
PROCHLORPERAZINEDiscontinued
PROCHLORPERAZINE EDISYLATE EQ 5MG BASE/ML · INJECTABLE · INJECTION
Approval history
1992-05-01Manufacturing (CMC) · Supplement 10AP
1992-03-04Manufacturing (CMC) · Supplement 11AP
1991-01-16Labeling · Supplement 12AP
1989-09-15Labeling · Supplement 9AP
1989-01-31Labeling · Supplement 8AP
1986-11-03Manufacturing (CMC) · Supplement 6AP
1984-03-23Manufacturing (CMC) · Supplement 3AP
1984-03-01Manufacturing (CMC) · Supplement 2AP
1983-03-09Manufacturing (CMC) · Supplement 1AP
1982-10-01OriginalAP
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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