APPLICATION
ANDA085788
TYPE
ANDA
ORIGINAL APPROVAL
1981-11-20
LATEST ACTION
2025-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TRIFLUOPERAZINE HYDROCHLORIDEPrescription
TRIFLUOPERAZINE HYDROCHLORIDE EQ 10MG BASE · TABLET · ORAL
Approval history
2025-01-22Labeling · Supplement 88 · standardAP
2025-01-15Labeling · Supplement 87 · standardAP
2011-07-26Labeling · Supplement 77AP
2010-12-06Labeling · Supplement 76AP
2008-11-25Labeling · Supplement 75AP
2002-12-16Manufacturing (CMC) · Supplement 71AP
2002-09-26Manufacturing (CMC) · Supplement 70AP
2002-04-19Manufacturing (CMC) · Supplement 69AP
2002-01-10Manufacturing (CMC) · Supplement 67AP
2001-11-28Labeling · Supplement 68AP
2001-08-22Manufacturing (CMC) · Supplement 65AP
2001-05-09Manufacturing (CMC) · Supplement 66AP
1999-06-15Labeling · Supplement 63AP
1999-06-15Manufacturing (CMC) · Supplement 61AP
1999-06-15Manufacturing (CMC) · Supplement 62AP
1999-05-05Manufacturing (CMC) · Supplement 60AP
1998-01-27Manufacturing (CMC) · Supplement 57AP
1997-10-21Manufacturing (CMC) · Supplement 59AP
1997-10-21Manufacturing (CMC) · Supplement 58AP
1997-10-21Manufacturing (CMC) · Supplement 56AP
1997-08-11Manufacturing (CMC) · Supplement 54AP
1997-08-11Manufacturing (CMC) · Supplement 55AP
1995-11-02Manufacturing (CMC) · Supplement 53AP
1994-01-24Manufacturing (CMC) · Supplement 52AP
1992-08-13Labeling · Supplement 51AP
1992-03-27Manufacturing (CMC) · Supplement 46AP
1992-03-27Manufacturing (CMC) · Supplement 50AP
1992-03-27Labeling · Supplement 47AP
1992-02-03Manufacturing (CMC) · Supplement 49AP
1989-09-15Labeling · Supplement 44AP
1989-09-15Labeling · Supplement 89AP
1988-11-02Labeling · Supplement 43AP
1988-01-21Manufacturing (CMC) · Supplement 38AP
1988-01-21Manufacturing (CMC) · Supplement 40AP
1988-01-21Manufacturing (CMC) · Supplement 39AP
1988-01-21Manufacturing (CMC) · Supplement 37AP
1987-01-20Manufacturing (CMC) · Supplement 33AP
1986-03-03Manufacturing (CMC) · Supplement 32AP
1986-01-17Manufacturing (CMC) · Supplement 28AP
1986-01-17Manufacturing (CMC) · Supplement 30AP
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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