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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088137
Company: CHARTWELL RX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE 200MG TABLET;ORAL Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
09/17/1986 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
02/23/2017 SUPPL-21 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

04/22/2016 SUPPL-20 Labeling

Label is not available on this site.

12/16/2002 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

09/05/2002 SUPPL-15 Labeling

Label is not available on this site.

02/21/2001 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

08/14/2001 SUPPL-13 Labeling

Label is not available on this site.

05/05/1999 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

03/21/1995 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

03/02/1992 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/09/1990 SUPPL-8 Labeling

Label is not available on this site.

09/28/1989 SUPPL-7 Labeling

Label is not available on this site.

11/10/1988 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/09/1987 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

01/09/1987 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

01/09/1987 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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