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 25MG BASE/ML | CONCENTRATE;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 |
|---|---|---|---|---|---|---|---|
| 01/31/1972 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 03/15/2001 | SUPPL-41 | 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-40 | Labeling |
Label is not available on this site. |
||
| 03/14/1997 | SUPPL-39 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/25/1991 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/15/1989 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/10/1989 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/20/1987 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/26/1987 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/09/1987 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 04/23/1987 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/09/1987 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 01/28/1987 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/24/1986 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 11/24/1986 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 11/24/1986 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 11/24/1986 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/10/1986 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/29/1984 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/05/1982 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 09/13/1982 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/14/1981 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 12/10/1980 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 01/16/1980 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/13/1980 | SUPPL-8 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 05/25/1976 | SUPPL-7 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 09/02/1975 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/31/1975 | SUPPL-5 | Labeling |
Label is not available on this site. |
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| 03/31/1975 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |