Drugs@FDA: FDA-Approved Drugs
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| TAVIST | CLEMASTINE FUMARATE | 2.68MG | TABLET;ORAL | Discontinued | None | Yes | No |
| TAVIST-1 | CLEMASTINE FUMARATE | 1.34MG | TABLET;ORAL | Discontinued | None | No | No |
| TAVIST-1 | CLEMASTINE FUMARATE | 1.34MG | 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 |
|---|---|---|---|---|---|---|---|
| 02/25/1977 | 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 |
|---|---|---|---|---|---|
| 02/11/2002 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/06/1996 | SUPPL-49 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/31/1996 | SUPPL-48 | Efficacy-New Indication |
Label is not available on this site. |
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| 10/20/1995 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/17/1995 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/07/1995 | SUPPL-45 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/08/1994 | SUPPL-44 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/03/1995 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 07/21/1994 | SUPPL-42 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/21/1993 | SUPPL-41 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/22/1993 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/07/1992 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 07/22/1992 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 02/21/1991 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/08/1992 | SUPPL-34 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/23/1992 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/04/1991 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/04/1992 | SUPPL-31 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/04/1987 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/16/1986 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/21/1992 | SUPPL-26 | Efficacy-Rx To OTC Switch |
Label is not available on this site. |
||
| 04/15/1986 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/01/1983 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/15/1981 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/17/1981 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/01/1980 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/01/1980 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/17/1980 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/20/1979 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 04/20/1979 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/14/1980 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/17/1978 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/11/1978 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 08/14/1978 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 08/14/1978 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/30/1978 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/30/1978 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/24/1978 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 03/16/1979 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 03/16/1979 | SUPPL-5 | Efficacy |
Label is not available on this site. |
||
| 02/16/1978 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 02/16/1978 | SUPPL-3 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/16/1979 | SUPPL-2 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |