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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088132
Company: CHARTWELL RX

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE 15MG 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
08/30/1983 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-46 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.
04/19/2016 SUPPL-45 Labeling-Package Insert

Label is not available on this site.
12/16/2002 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.
09/05/2002 SUPPL-40 Labeling

Label is not available on this site.
02/21/2001 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.
08/14/2001 SUPPL-38 Labeling

Label is not available on this site.
05/05/1999 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.
09/18/1998 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.
10/20/1998 SUPPL-34 Labeling

Label is not available on this site.
10/20/1998 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.
03/21/1995 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.
01/02/1990 SUPPL-31 Labeling

Label is not available on this site.
09/28/1989 SUPPL-30 Labeling

Label is not available on this site.
11/10/1988 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.
07/15/1987 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.
07/15/1987 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.
07/15/1987 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.
04/18/1986 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.
09/03/1986 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.
04/18/1986 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.
10/30/1984 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.
10/30/1984 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.
10/30/1984 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.
10/30/1984 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
10/30/1984 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
06/28/1984 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.
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