Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011808
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MELLARIL THIORIDAZINE HYDROCHLORIDE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
MELLARIL THIORIDAZINE HYDROCHLORIDE 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
MELLARIL THIORIDAZINE HYDROCHLORIDE 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
MELLARIL THIORIDAZINE HYDROCHLORIDE 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
MELLARIL THIORIDAZINE HYDROCHLORIDE 30MG/ML CONCENTRATE;ORAL Discontinued None No No
MELLARIL THIORIDAZINE HYDROCHLORIDE 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
MELLARIL THIORIDAZINE HYDROCHLORIDE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
MELLARIL THIORIDAZINE HYDROCHLORIDE 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
MELLARIL THIORIDAZINE HYDROCHLORIDE 100MG/ML CONCENTRATE;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
03/15/1962 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/28/2001 SUPPL-179 Manufacturing (CMC)

Label is not available on this site.

03/15/2001 SUPPL-178 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17923S49LTR.PDF
06/15/2001 SUPPL-177 Manufacturing (CMC)

Label is not available on this site.

03/01/2000 SUPPL-176 Manufacturing (CMC)

Label is not available on this site.

06/19/2000 SUPPL-175 Labeling

Label is not available on this site.

04/15/1999 SUPPL-173 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/25/1999 SUPPL-172 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

01/15/1997 SUPPL-170 Manufacturing (CMC)-Control

Label is not available on this site.

03/20/1996 SUPPL-169 Manufacturing (CMC)-Control

Label is not available on this site.

11/22/1995 SUPPL-168 Manufacturing (CMC)

Label is not available on this site.

10/17/1995 SUPPL-165 Manufacturing (CMC)-Control

Label is not available on this site.

12/02/1994 SUPPL-138 Manufacturing (CMC)-Formulation

Label is not available on this site.

11/28/1994 SUPPL-117 Manufacturing (CMC)-Control

Label is not available on this site.

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