Drugs@FDA: FDA-Approved Drugs
Company: NOVARTIS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
SANOREX | MAZINDOL | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
SANOREX | MAZINDOL | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
06/14/1973 | 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 |
---|---|---|---|---|---|
09/17/2001 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
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02/27/1996 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
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10/17/1995 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/19/1994 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/13/1995 | SUPPL-37 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/27/1992 | SUPPL-36 | Labeling |
Label is not available on this site. |
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08/02/1991 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/29/1994 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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03/14/1990 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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09/14/1989 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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11/18/1986 | SUPPL-29 | Labeling |
Label is not available on this site. |
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06/25/1981 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
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01/21/1981 | SUPPL-26 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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01/06/1982 | SUPPL-25 | Labeling |
Label is not available on this site. |
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01/16/1979 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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03/23/1979 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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09/19/1979 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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06/28/1977 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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09/20/1976 | SUPPL-19 | Labeling |
Label is not available on this site. |
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05/10/1976 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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03/31/1976 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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10/06/1975 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/15/1974 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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11/15/1974 | SUPPL-11 | Labeling |
Label is not available on this site. |
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11/15/1974 | SUPPL-10 | Labeling |
Label is not available on this site. |