Drugs@FDA: FDA-Approved Drugs
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VISKEN | PINDOLOL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
VISKEN | PINDOLOL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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. |
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04/28/1999 | SUPPL-32 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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02/24/1999 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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12/14/1998 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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10/15/1998 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/09/1997 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/02/1995 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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03/07/1995 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/15/1993 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/21/1992 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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01/14/1992 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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08/19/1992 | SUPPL-22 | Labeling |
Label is not available on this site. |
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09/03/1991 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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12/04/1991 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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01/10/1990 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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01/11/1990 | SUPPL-17 | Labeling |
Label is not available on this site. |
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10/23/1989 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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05/01/1989 | SUPPL-15 | Labeling |
Label is not available on this site. |
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10/26/1989 | SUPPL-14 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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10/27/1988 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/23/1987 | SUPPL-12 | Labeling |
Label is not available on this site. |
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07/08/1986 | SUPPL-11 | Labeling |
Label is not available on this site. |
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06/10/1987 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/20/1986 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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02/20/1986 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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07/16/1985 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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03/21/1985 | SUPPL-5 | Labeling |
Label is not available on this site. |
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07/20/1984 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/02/1983 | SUPPL-3 | Efficacy |
Label is not available on this site. |
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01/11/1983 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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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 |