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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 088869
Company: WATSON LABS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE 150MG 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
06/28/1985 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-13 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/03/2015 SUPPL-12 Labeling-Package Insert

Label is not available on this site.

08/09/1990 SUPPL-10 Labeling

Label is not available on this site.

01/28/1991 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

11/23/1992 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

11/23/1992 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

11/23/1992 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

11/23/1992 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

06/29/1990 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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