Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088738
Company: SUN PHARM INDUSTRIES
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
THIORIDAZINE HYDROCHLORIDE THIORIDAZINE HYDROCHLORIDE 200MG 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
10/16/1984 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
02/23/2017 SUPPL-24 Labeling-Package Insert

Label is not available on this site.

12/03/2010 SUPPL-23 Labeling-Package Insert

Label is not available on this site.

12/01/1998 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

12/23/1994 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

10/11/1994 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/03/1992 SUPPL-17 Manufacturing (CMC)

Label is not available on this site.

04/05/1990 SUPPL-16 Bioequivalence

Label is not available on this site.

02/23/1990 SUPPL-15 Labeling

Label is not available on this site.

08/19/1988 SUPPL-14 Labeling

Label is not available on this site.

06/02/1988 SUPPL-13 Labeling

Label is not available on this site.

12/28/1987 SUPPL-11 Manufacturing (CMC)

Label is not available on this site.

10/01/1987 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

10/01/1987 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

04/03/1987 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/25/1986 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

07/25/1986 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

02/11/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

02/11/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

04/23/1985 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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