APPLICATION
ANDA085785
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 1MG BASE · TABLET · ORAL
Approval history
2025-01-22Labeling · Supplement 85 · standardAP
2025-01-15Labeling · Supplement 84 · standardAP
2011-07-26Labeling · Supplement 75AP
2010-12-06Labeling · Supplement 74AP
2008-11-25Labeling · Supplement 73AP
2002-10-18Manufacturing (CMC) · Supplement 68AP
2002-04-19Manufacturing (CMC) · Supplement 67AP
2001-11-28Labeling · Supplement 66AP
2001-08-22Manufacturing (CMC) · Supplement 64AP
2001-05-09Manufacturing (CMC) · Supplement 65AP
1999-06-15Manufacturing (CMC) · Supplement 63AP
1999-05-05Manufacturing (CMC) · Supplement 62AP
1999-03-26Labeling · Supplement 61AP
1999-03-26Manufacturing (CMC) · Supplement 60AP
1998-02-02Manufacturing (CMC) · Supplement 57AP
1998-02-02Manufacturing (CMC) · Supplement 58AP
1998-02-02Manufacturing (CMC) · Supplement 59AP
1997-08-11Manufacturing (CMC) · Supplement 55AP
1997-08-11Manufacturing (CMC) · Supplement 56AP
1996-01-23Manufacturing (CMC) · Supplement 54AP
1994-01-24Manufacturing (CMC) · Supplement 53AP
1992-08-13Labeling · Supplement 52AP
1992-03-27Manufacturing (CMC) · Supplement 49AP
1992-03-27Manufacturing (CMC) · Supplement 47AP
1992-03-27Labeling · Supplement 48AP
1992-02-03Manufacturing (CMC) · Supplement 51AP
1989-09-15Labeling · Supplement 45AP
1989-09-15Labeling · Supplement 87AP
1988-11-02Labeling · Supplement 44AP
1988-01-21Manufacturing (CMC) · Supplement 39AP
1988-01-21Manufacturing (CMC) · Supplement 41AP
1988-01-21Manufacturing (CMC) · Supplement 38AP
1988-01-21Manufacturing (CMC) · Supplement 40AP
1987-01-20Manufacturing (CMC) · Supplement 34AP
1986-03-03Manufacturing (CMC) · Supplement 33AP
1986-01-17Manufacturing (CMC) · Supplement 29AP
1986-01-17Manufacturing (CMC) · Supplement 31AP
1986-01-17Manufacturing (CMC) · Supplement 30AP
1985-04-09Manufacturing (CMC) · Supplement 25AP
1985-01-07Manufacturing (CMC) · Supplement 24AP
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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