Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088479
Company: HERITAGE PHARMA
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
11/08/1983 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-17 Labeling-Package Insert

Label is not available on this site.

11/03/2015 SUPPL-16 Labeling-Package Insert

Label is not available on this site.

08/09/1990 SUPPL-14 Labeling

Label is not available on this site.

01/28/1991 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

08/07/1991 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

08/10/1989 SUPPL-10 Bioequivalence

Label is not available on this site.

08/10/1989 SUPPL-9 Bioequivalence

Label is not available on this site.

06/29/1990 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

11/15/1984 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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