APPLICATION
ANDA080365
TYPE
ANDA
ORIGINAL APPROVAL
1974-02-13
LATEST ACTION
2020-02-05
ROUTE
INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
CHLORPROMAZINE HYDROCHLORIDEPrescription
CHLORPROMAZINE HYDROCHLORIDE 25MG/ML · INJECTABLE · INJECTION
Approval history
2020-02-05Labeling · Supplement 167 · standardAP
2017-02-23Labeling · Supplement 166 · standardAP
2015-11-03Labeling · Supplement 165AP
1999-02-19Manufacturing (CMC) · Supplement 163AP
1999-02-02Manufacturing (CMC) · Supplement 162AP
1998-03-27Manufacturing (CMC) · Supplement 160AP
1996-12-04Manufacturing (CMC) · Supplement 161AP
1995-08-16Manufacturing (CMC) · Supplement 159AP
1992-05-27Manufacturing (CMC) · Supplement 157AP
1992-05-11Labeling · Supplement 158AP
1991-07-02Manufacturing (CMC) · Supplement 151AP
1991-07-02Manufacturing (CMC) · Supplement 152AP
1991-07-02Manufacturing (CMC) · Supplement 150AP
1991-04-10Labeling · Supplement 156AP
1990-01-11Labeling · Supplement 155AP
1989-10-16Manufacturing (CMC) · Supplement 149AP
1989-10-16Manufacturing (CMC) · Supplement 153AP
1989-10-16Manufacturing (CMC) · Supplement 148AP
1989-04-20Bioequivalence · Supplement 138AP
1989-04-18Manufacturing (CMC) · Supplement 147AP
1989-04-18Manufacturing (CMC) · Supplement 145AP
1989-04-18Manufacturing (CMC) · Supplement 146AP
1989-04-10Bioequivalence · Supplement 139AP
1988-06-30Labeling · Supplement 41AP
1986-06-16Manufacturing (CMC) · Supplement 137AP
1974-02-13OriginalAP
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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