APPLICATION
ANDA088157
TYPE
ANDA
ORIGINAL APPROVAL
1983-04-27
LATEST ACTION
2001-11-28
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Discontinued
Products
CHLORPROMAZINE HYDROCHLORIDE INTENSOLDiscontinued
CHLORPROMAZINE HYDROCHLORIDE 30MG/ML · CONCENTRATE · ORAL
Approval history
2001-11-28Labeling · Supplement 9AP
1999-08-24Labeling · Supplement 8AP
1996-08-28Manufacturing (CMC) · Supplement 7AP
1995-04-06Manufacturing (CMC) · Supplement 6AP
1992-11-03Labeling · Supplement 5AP
1988-09-23Bioequivalence · Supplement 1AP
1988-09-13Manufacturing (CMC) · Supplement 3AP
1988-09-13Manufacturing (CMC) · Supplement 4AP
1983-04-27OriginalAP
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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