Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016997
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SERENTIL MESORIDAZINE BESYLATE EQ 25MG BASE/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
01/31/1972 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-41 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/16997S41LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/16-774S073.pdf
09/06/2000 SUPPL-40 Labeling

Label is not available on this site.

03/14/1997 SUPPL-39 Manufacturing (CMC)-Control

Label is not available on this site.

01/25/1991 SUPPL-34 Manufacturing (CMC)

Label is not available on this site.

08/15/1989 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

05/10/1989 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

08/20/1987 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

05/26/1987 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

06/09/1987 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/23/1987 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

06/09/1987 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/28/1987 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

11/24/1986 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/24/1986 SUPPL-21 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/24/1986 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/24/1986 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/10/1986 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

05/29/1984 SUPPL-15 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/05/1982 SUPPL-14 Labeling

Label is not available on this site.

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

Label is not available on this site.

05/14/1981 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/10/1980 SUPPL-10 Labeling

Label is not available on this site.

01/16/1980 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

05/13/1980 SUPPL-8 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/25/1976 SUPPL-7 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/02/1975 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

03/31/1975 SUPPL-5 Labeling

Label is not available on this site.

03/31/1975 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

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