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FDA ANDA · ANDA089953

THIORIDAZINE HYDROCHLORIDE

Sponsor: SUN PHARM INDUSTRIES

APPLICATION
ANDA089953
TYPE
ANDA
ORIGINAL APPROVAL
1988-10-07
LATEST ACTION
2017-02-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

THIORIDAZINE HYDROCHLORIDEDiscontinued
THIORIDAZINE HYDROCHLORIDE 25MG · TABLET · ORAL
THIORIDAZINE HYDROCHLORIDEDiscontinued
THIORIDAZINE HYDROCHLORIDE 100MG · TABLET · ORAL
THIORIDAZINE HYDROCHLORIDEDiscontinued
THIORIDAZINE HYDROCHLORIDE 10MG · TABLET · ORAL
THIORIDAZINE HYDROCHLORIDEDiscontinued
THIORIDAZINE HYDROCHLORIDE 50MG · TABLET · ORAL

Approval history

2017-02-23Labeling · Supplement 37 · standardAP
2010-12-03Labeling · Supplement 33AP
2002-06-25Manufacturing (CMC) · Supplement 16AP
2001-09-19Manufacturing (CMC) · Supplement 14AP
2001-09-17Manufacturing (CMC) · Supplement 15AP
2000-10-02Manufacturing (CMC) · Supplement 12AP
2000-10-02Labeling · Supplement 13AP
2000-05-16Manufacturing (CMC) · Supplement 10AP
2000-05-16Manufacturing (CMC) · Supplement 11AP
1998-05-06Manufacturing (CMC) · Supplement 9AP
1997-12-05Manufacturing (CMC) · Supplement 8AP
1997-02-24Manufacturing (CMC) · Supplement 7AP
1995-06-22Manufacturing (CMC) · Supplement 6AP
1994-01-12Manufacturing (CMC) · Supplement 5AP
1990-02-01Labeling · Supplement 2AP
1988-10-07OriginalAP
VIEW ON DRUGS@FDA ↗

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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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