APPLICATION
ANDA080439
TYPE
ANDA
ORIGINAL APPROVAL
1973-01-03
LATEST ACTION
2020-02-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CHLORPROMAZINE HYDROCHLORIDEDiscontinued
CHLORPROMAZINE HYDROCHLORIDE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
CHLORPROMAZINE HYDROCHLORIDEDiscontinued
CHLORPROMAZINE HYDROCHLORIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
CHLORPROMAZINE HYDROCHLORIDEDiscontinued
CHLORPROMAZINE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
CHLORPROMAZINE HYDROCHLORIDEDiscontinued
CHLORPROMAZINE HYDROCHLORIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
CHLORPROMAZINE HYDROCHLORIDEDiscontinued
CHLORPROMAZINE HYDROCHLORIDE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2020-02-05Labeling · Supplement 225 · standardAP
2017-02-23Labeling · Supplement 224 · standardAP
2010-12-03Labeling · Supplement 222AP
2009-07-21Labeling · Supplement 221AP
2008-09-08Labeling · Supplement 220AP
2008-08-19Labeling · Supplement 217AP
2002-12-16Manufacturing (CMC) · Supplement 211AP
2002-03-08Manufacturing (CMC) · Supplement 208AP
2001-11-09Manufacturing (CMC) · Supplement 205AP
2001-11-09Manufacturing (CMC) · Supplement 206AP
2001-10-24Labeling · Supplement 209AP
2001-10-24Labeling · Supplement 210AP
2001-05-09Manufacturing (CMC) · Supplement 207AP
1999-05-21Manufacturing (CMC) · Supplement 204AP
1999-05-05Manufacturing (CMC) · Supplement 203AP
1998-11-20Labeling · Supplement 200AP
1998-11-20Manufacturing (CMC) · Supplement 199AP
1998-10-08Manufacturing (CMC) · Supplement 201AP
1998-08-20Labeling · Supplement 202AP
1995-10-23Manufacturing (CMC) · Supplement 198AP
1995-02-02Manufacturing (CMC) · Supplement 197AP
1990-03-30Labeling · Supplement 195AP
1989-11-09Labeling · Supplement 194AP
1988-11-15Manufacturing (CMC) · Supplement 180AP
1988-11-15Manufacturing (CMC) · Supplement 172AP
1988-11-15Manufacturing (CMC) · Supplement 170AP
1988-11-15Labeling · Supplement 187AP
1988-11-15Labeling · Supplement 179AP
1988-11-15Manufacturing (CMC) · Supplement 185AP
1988-11-15Manufacturing (CMC) · Supplement 177AP
1988-11-15Manufacturing (CMC) · Supplement 169AP
1988-11-15Labeling · Supplement 183AP
1988-11-15Labeling · Supplement 175AP
1988-11-15Manufacturing (CMC) · Supplement 181AP
1988-11-15Manufacturing (CMC) · Supplement 173AP
1988-11-15Labeling · Supplement 171AP
1988-11-15Manufacturing (CMC) · Supplement 186AP
1988-11-15Manufacturing (CMC) · Supplement 184AP
1988-11-15Manufacturing (CMC) · Supplement 176AP
1988-11-15Manufacturing (CMC) · Supplement 182AP
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.