Drugs@FDA: FDA-Approved Drugs
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MELLARIL-S | THIORIDAZINE | EQ 25MG HYDROCHLORIDE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION;ORAL | Discontinued | None | No | No |
| MELLARIL-S | THIORIDAZINE | EQ 100MG HYDROCHLORIDE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUSPENSION;ORAL | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|---|---|
| 10/18/1978 | 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-49 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17923S49LTR.PDF |
| 06/19/2000 | SUPPL-48 | Labeling |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-47 | Labeling |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 05/02/1989 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-33 | Labeling |
Label is not available on this site. |
||
| 08/20/1987 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/26/1987 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/23/1987 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/13/1987 | SUPPL-28 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 10/06/1986 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 10/06/1986 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 11/10/1986 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 11/15/1988 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/10/1986 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 09/20/1982 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/13/1982 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/30/1982 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 01/13/1981 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/18/1981 | SUPPL-11 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 01/09/1981 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/10/1980 | SUPPL-8 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/15/1980 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/15/1979 | SUPPL-6 | Unspecified |
Label is not available on this site. |
||
| 10/15/1979 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/14/1979 | SUPPL-4 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/11/1979 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/15/1980 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-1 | Labeling |
Label is not available on this site. |