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 | INJECTABLE;INJECTION | 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 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 |
|---|---|---|---|---|---|
| 03/28/2001 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 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. |
||
| 08/01/1994 | SUPPL-36 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/22/1989 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/15/1989 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/21/1988 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/10/1989 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/20/1987 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/26/1987 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/23/1987 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/24/1986 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/10/1986 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/26/1984 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/18/1982 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/05/1982 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 11/16/1982 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/19/1981 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/10/1980 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 01/16/1980 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/30/1979 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/05/1977 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/19/1977 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/31/1975 | SUPPL-4 | 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. |