Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017923
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MELLARIL-S THIORIDAZINE EQ 25MG HYDROCHLORIDE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SUSPENSION;ORAL Discontinued None No No
MELLARIL-S THIORIDAZINE EQ 100MG HYDROCHLORIDE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** SUSPENSION;ORAL Discontinued None No No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
10/18/1978 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
03/15/2001 SUPPL-49 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17923S49LTR.PDF
06/19/2000 SUPPL-48 Labeling

Label is not available on this site.

12/07/2007 SUPPL-47 Labeling

Label is not available on this site.

12/07/2007 SUPPL-46 Labeling

Label is not available on this site.

12/07/2007 SUPPL-45 Labeling

Label is not available on this site.

12/07/2007 SUPPL-42 Labeling

Label is not available on this site.

12/07/2007 SUPPL-41 Labeling

Label is not available on this site.

12/07/2007 SUPPL-40 Labeling

Label is not available on this site.

12/07/2007 SUPPL-39 Labeling

Label is not available on this site.

12/07/2007 SUPPL-38 Labeling

Label is not available on this site.

12/07/2007 SUPPL-37 Labeling

Label is not available on this site.

12/07/2007 SUPPL-36 Labeling

Label is not available on this site.

05/02/1989 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/2007 SUPPL-34 Labeling

Label is not available on this site.

12/07/2007 SUPPL-33 Labeling

Label is not available on this site.

08/20/1987 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

05/26/1987 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

04/23/1987 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

03/13/1987 SUPPL-28 Manufacturing (CMC)-Formulation

Label is not available on this site.

10/06/1986 SUPPL-27 Labeling

Label is not available on this site.

10/06/1986 SUPPL-26 Labeling

Label is not available on this site.

11/10/1986 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/2007 SUPPL-24 Labeling

Label is not available on this site.

11/15/1988 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

06/10/1986 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/2007 SUPPL-21 Labeling

Label is not available on this site.

12/07/2007 SUPPL-20 Labeling

Label is not available on this site.

12/07/2007 SUPPL-19 Labeling

Label is not available on this site.

12/07/2007 SUPPL-18 Labeling

Label is not available on this site.

12/07/2007 SUPPL-17 Labeling

Label is not available on this site.

09/20/1982 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

09/13/1982 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

04/30/1982 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

12/07/2007 SUPPL-13 Labeling

Label is not available on this site.

01/13/1981 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/18/1981 SUPPL-11 Manufacturing (CMC)-Formulation

Label is not available on this site.

01/09/1981 SUPPL-10 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/10/1980 SUPPL-8 Manufacturing (CMC)-Formulation

Label is not available on this site.

04/15/1980 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

10/15/1979 SUPPL-6 Unspecified

Label is not available on this site.

10/15/1979 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/14/1979 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/11/1979 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/15/1980 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

12/07/2007 SUPPL-1 Labeling

Label is not available on this site.

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