Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016774
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SERENTIL MESORIDAZINE BESYLATE EQ 10MG BASE TABLET;ORAL Discontinued None No No
SERENTIL MESORIDAZINE BESYLATE EQ 25MG BASE TABLET;ORAL Discontinued None No No
SERENTIL MESORIDAZINE BESYLATE EQ 50MG BASE TABLET;ORAL Discontinued None No No
SERENTIL MESORIDAZINE BESYLATE EQ 100MG BASE 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
02/27/1970 ORIG-1 Approval Type 1 - New Molecular Entity 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
03/28/2001 SUPPL-75 Manufacturing (CMC)

Label is not available on this site.

07/06/2001 SUPPL-74 Manufacturing (CMC)

Label is not available on this site.

03/15/2001 SUPPL-73 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-72 Labeling

Label is not available on this site.

03/14/1997 SUPPL-71 Manufacturing (CMC)-Control

Label is not available on this site.

11/22/1995 SUPPL-70 Manufacturing (CMC)

Label is not available on this site.

10/17/1995 SUPPL-69 Manufacturing (CMC)-Control

Label is not available on this site.

08/01/1994 SUPPL-66 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/30/1990 SUPPL-62 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/01/1994 SUPPL-61 Manufacturing (CMC)-Control

Label is not available on this site.

11/03/1989 SUPPL-59 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/15/1989 SUPPL-58 Manufacturing (CMC)

Label is not available on this site.

05/10/1989 SUPPL-57 Manufacturing (CMC)-Control

Label is not available on this site.

03/14/1990 SUPPL-56 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/20/1987 SUPPL-54 Manufacturing (CMC)-Control

Label is not available on this site.

05/26/1987 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

04/23/1987 SUPPL-52 Manufacturing (CMC)-Control

Label is not available on this site.

03/24/1986 SUPPL-50 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/23/1985 SUPPL-49 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/08/1985 SUPPL-47 Manufacturing (CMC)

Label is not available on this site.

03/14/1984 SUPPL-46 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/17/1986 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

11/05/1982 SUPPL-43 Labeling

Label is not available on this site.

01/19/1983 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

06/22/1981 SUPPL-41 Manufacturing (CMC)

Label is not available on this site.

03/24/1981 SUPPL-39 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/10/1980 SUPPL-38 Labeling

Label is not available on this site.

03/07/1980 SUPPL-37 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/16/1980 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.

04/04/1979 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

08/30/1979 SUPPL-34 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/12/1978 SUPPL-33 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/08/1978 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/03/1977 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

06/03/1977 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/1978 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

09/15/1976 SUPPL-28 Labeling

Label is not available on this site.

05/25/1976 SUPPL-27 Manufacturing (CMC)-Formulation

Label is not available on this site.

08/03/1976 SUPPL-26 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/16/1976 SUPPL-25 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/02/1975 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

07/01/1975 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

05/06/1975 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

03/31/1975 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

06/07/1974 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

01/30/1975 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

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