APPLICATION
ANDA087053
TYPE
ANDA
ORIGINAL APPROVAL
1981-02-04
LATEST ACTION
1990-11-16
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Discontinued
Products
CHLORPROMAZINE HYDROCHLORIDEDiscontinued
CHLORPROMAZINE HYDROCHLORIDE 100MG/ML · CONCENTRATE · ORAL
Approval history
1990-11-16Labeling · Supplement 15AP
1990-04-04Labeling · Supplement 14AP
1989-06-22Labeling · Supplement 12AP
1989-06-22Labeling · Supplement 13AP
1988-07-28Manufacturing (CMC) · Supplement 10AP
1988-07-28Manufacturing (CMC) · Supplement 9AP
1988-07-28Manufacturing (CMC) · Supplement 11AP
1987-05-18Manufacturing (CMC) · Supplement 6AP
1985-08-09Manufacturing (CMC) · Supplement 3AP
1981-02-04OriginalAP
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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