APPLICATION
ANDA083386
TYPE
ANDA
ORIGINAL APPROVAL
1974-07-09
LATEST ACTION
2020-02-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CHLORPROMAZINE HYDROCHLORIDE · ReferencePrescription
CHLORPROMAZINE HYDROCHLORIDE 10MG · TABLET · ORAL
Approval history
2020-02-05Labeling · Supplement 98 · standardAP
2017-02-23Labeling · Supplement 95 · standardAP
2016-08-29Labeling · Supplement 94 · standardAP
2011-09-13Labeling · Supplement 90AP
2010-12-03Labeling · Supplement 87AP
2009-08-18Labeling · Supplement 84AP
2008-11-19Labeling · Supplement 81AP
2002-11-25Labeling · Supplement 66AP
1999-03-22Labeling · Supplement 65AP
1999-03-22Manufacturing (CMC) · Supplement 64AP
1996-02-05Manufacturing (CMC) · Supplement 63AP
1992-09-16Labeling · Supplement 62AP
1991-12-31Labeling · Supplement 61AP
1990-11-29Labeling · Supplement 60AP
1989-04-14Manufacturing (CMC) · Supplement 59AP
1988-10-24Manufacturing (CMC) · Supplement 58AP
1988-04-26Labeling · Supplement 57AP
1988-04-14Manufacturing (CMC) · Supplement 54AP
1988-03-08Labeling · Supplement 55AP
1987-12-08Manufacturing (CMC) · Supplement 50AP
1987-12-08Manufacturing (CMC) · Supplement 53AP
1987-12-08Manufacturing (CMC) · Supplement 51AP
1986-07-10Manufacturing (CMC) · Supplement 49AP
1986-07-10Manufacturing (CMC) · Supplement 48AP
1986-03-10Manufacturing (CMC) · Supplement 46AP
1984-11-26Manufacturing (CMC) · Supplement 44AP
1984-11-26Manufacturing (CMC) · Supplement 45AP
1984-11-26Manufacturing (CMC) · Supplement 43AP
1974-07-09OriginalAP
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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