Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018285
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
VISKEN PINDOLOL 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
VISKEN PINDOLOL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
09/03/1982 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
10/27/2007 SUPPL-34 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018285s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018285s034ltr.pdf
04/02/2001 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

04/28/1999 SUPPL-32 Manufacturing (CMC)-Packaging

Label is not available on this site.

02/24/1999 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

12/14/1998 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

10/15/1998 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

09/09/1997 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

11/02/1995 SUPPL-27 Manufacturing (CMC)

Label is not available on this site.

03/07/1995 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

12/15/1993 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

09/21/1992 SUPPL-24 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/14/1992 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

08/19/1992 SUPPL-22 Labeling

Label is not available on this site.

09/03/1991 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

12/04/1991 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.

01/10/1990 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

01/11/1990 SUPPL-17 Labeling

Label is not available on this site.

10/23/1989 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/01/1989 SUPPL-15 Labeling

Label is not available on this site.

10/26/1989 SUPPL-14 Manufacturing (CMC)-Packaging

Label is not available on this site.

10/27/1988 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

07/23/1987 SUPPL-12 Labeling

Label is not available on this site.

07/08/1986 SUPPL-11 Labeling

Label is not available on this site.

06/10/1987 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

02/20/1986 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.

02/20/1986 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

07/16/1985 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

03/21/1985 SUPPL-5 Labeling

Label is not available on this site.

07/20/1984 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

06/02/1983 SUPPL-3 Efficacy

Label is not available on this site.

01/11/1983 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/05/1982 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/27/2007 SUPPL-34 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/018285s034lbl.pdf

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