Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088563
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE 50MG 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
05/11/1984 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
02/24/2017 SUPPL-29 Labeling-Package Insert

Label is not available on this site.

11/03/2015 SUPPL-28 Labeling-Package Insert

Label is not available on this site.

01/31/1997 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

02/04/1991 SUPPL-26 Labeling

Label is not available on this site.

09/17/1990 SUPPL-25 Labeling

Label is not available on this site.

09/27/1988 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

09/27/1988 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

09/27/1988 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

07/05/1988 SUPPL-21 Labeling

Label is not available on this site.

10/26/1987 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

05/15/1987 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

02/05/1986 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

11/25/1985 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

11/25/1985 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

11/25/1985 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

01/11/1985 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

01/11/1985 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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