Drugs@FDA: FDA-Approved Drugs
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| SERENTIL | MESORIDAZINE BESYLATE | EQ 10MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |
| SERENTIL | MESORIDAZINE BESYLATE | EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |
| SERENTIL | MESORIDAZINE BESYLATE | EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |
| SERENTIL | MESORIDAZINE BESYLATE | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |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. |
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| 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. |
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| 10/17/1995 | SUPPL-69 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 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. |
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| 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. |
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| 03/24/1986 | SUPPL-50 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 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. |
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| 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. |
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| 03/07/1980 | SUPPL-37 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 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. |
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| 01/30/1975 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |