APPLICATION
ANDA086863
TYPE
ANDA
ORIGINAL APPROVAL
1980-11-07
LATEST ACTION
2017-02-23
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Discontinued
Products
CHLORPROMAZINE HYDROCHLORIDEDiscontinued
CHLORPROMAZINE HYDROCHLORIDE 100MG/ML · CONCENTRATE · ORAL
Approval history
2017-02-23Labeling · Supplement 29 · standardAP
2015-11-03Labeling · Supplement 28AP
2002-04-30Manufacturing (CMC) · Supplement 23AP
2002-01-16Manufacturing (CMC) · Supplement 22AP
2000-10-02Manufacturing (CMC) · Supplement 21AP
1999-12-15Labeling · Supplement 20AP
1999-09-02Labeling · Supplement 19AP
1997-09-25Manufacturing (CMC) · Supplement 17AP
1992-08-13Manufacturing (CMC) · Supplement 10AP
1991-10-28Manufacturing (CMC) · Supplement 15AP
1990-09-28Manufacturing (CMC) · Supplement 14AP
1989-11-09Labeling · Supplement 13AP
1988-07-26Manufacturing (CMC) · Supplement 9AP
1987-01-14Manufacturing (CMC) · Supplement 5AP
1987-01-14Manufacturing (CMC) · Supplement 6AP
1983-01-31Manufacturing (CMC) · Supplement 2AP
1980-11-07OriginalAP
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.