Drugs@FDA: FDA-Approved Drugs
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MESANTOIN | MEPHENYTOIN | 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 10/23/1946 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/02/2001 | SUPPL-49 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/23/1999 | SUPPL-48 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/15/1997 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/21/1996 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/15/1995 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/14/1995 | SUPPL-43 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/14/1994 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 12/14/1994 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 11/23/1994 | SUPPL-40 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/23/1996 | SUPPL-39 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 07/01/1994 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/10/1987 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 08/27/1986 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/05/1984 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/27/1986 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/08/1983 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/20/1981 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/06/1981 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/24/1980 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 06/14/1979 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/28/1978 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/13/1978 | SUPPL-23 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/18/1977 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/20/1976 | SUPPL-21 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/23/1976 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/04/1976 | SUPPL-19 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 05/04/1976 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/01/1975 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/10/1975 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 09/20/1974 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 08/29/1974 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |