Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 088456
Company: ANI PHARMS INC
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
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/17/1985 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
02/16/1995 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

10/26/1994 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/30/1987 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

04/16/1986 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.

04/16/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

03/21/1986 SUPPL-3 Manufacturing (CMC)

Label is not available on this site.

03/21/1986 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

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