APPLICATION
ANDA083329
TYPE
ANDA
ORIGINAL APPROVAL
1974-07-25
LATEST ACTION
2020-02-05
ROUTE
INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
CHLORPROMAZINE HYDROCHLORIDE · ReferencePrescription
CHLORPROMAZINE HYDROCHLORIDE 25MG/ML · INJECTABLE · INJECTION
Approval history
2020-02-05Labeling · Supplement 47 · standardAP
2020-02-04Labeling · Supplement 46 · standardAP
2010-12-03Labeling · Supplement 43AP
2009-06-29Labeling · Supplement 42AP
2008-11-25Labeling · Supplement 41AP
2002-11-25Labeling · Supplement 35AP
2000-09-18Manufacturing (CMC) · Supplement 34AP
1999-10-06Manufacturing (CMC) · Supplement 32AP
1999-10-06Manufacturing (CMC) · Supplement 33AP
1999-09-07Manufacturing (CMC) · Supplement 30AP
1999-09-07Manufacturing (CMC) · Supplement 31AP
1999-04-14Labeling · Supplement 29AP
1998-03-19Manufacturing (CMC) · Supplement 28AP
1993-12-09Manufacturing (CMC) · Supplement 27AP
1992-02-27Manufacturing (CMC) · Supplement 25AP
1991-01-28Labeling · Supplement 26AP
1989-11-08Labeling · Supplement 24AP
1989-02-15Manufacturing (CMC) · Supplement 22AP
1989-02-15Manufacturing (CMC) · Supplement 21AP
1974-07-25OriginalAP
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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