Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 089953
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE 100MG TABLET;ORAL Discontinued None No No
THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE 50MG TABLET;ORAL Discontinued None No No
THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE 25MG TABLET;ORAL Discontinued None No No
THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE 10MG 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
10/07/1988 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-37 Labeling-Package Insert

Label is not available on this site.

12/03/2010 SUPPL-33 Labeling-Package Insert

Label is not available on this site.

06/25/2002 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/17/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

09/19/2001 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

10/02/2000 SUPPL-13 Labeling

Label is not available on this site.

10/02/2000 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/16/2000 SUPPL-11 Manufacturing (CMC)-Facility

Label is not available on this site.

05/16/2000 SUPPL-10 Manufacturing (CMC)-Facility

Label is not available on this site.

05/06/1998 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

12/05/1997 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

02/24/1997 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

06/22/1995 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

01/12/1994 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

02/01/1990 SUPPL-2 Labeling

Label is not available on this site.

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