Drugs@FDA: FDA-Approved Drugs
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LUDIOMIL | MAPROTILINE HYDROCHLORIDE | 25MG | TABLET;ORAL | Discontinued | None | No | No |
| LUDIOMIL | MAPROTILINE HYDROCHLORIDE | 50MG | TABLET;ORAL | Discontinued | None | No | No |
| LUDIOMIL | MAPROTILINE HYDROCHLORIDE | 75MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/01/1980 | 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 |
|---|---|---|---|---|---|
| 04/10/1997 | SUPPL-30 | Labeling |
Label is not available on this site. |
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| 04/10/1997 | SUPPL-29 | Labeling |
Label is not available on this site. |
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| 03/05/1996 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
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| 11/28/1994 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/10/1997 | SUPPL-26 | Labeling |
Label is not available on this site. |
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| 07/12/1993 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/28/1994 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/27/1990 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/10/1997 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 04/07/1989 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 04/10/1997 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 04/10/1997 | SUPPL-18 | Labeling |
Label is not available on this site. |
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| 03/21/1985 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/26/1985 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 11/04/1983 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/16/1983 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 11/17/1982 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 11/08/1982 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 10/21/1982 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 01/12/1983 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 08/03/1981 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 08/03/1981 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/03/1981 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/03/1981 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/03/1981 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 09/30/1982 | SUPPL-2 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 05/29/1981 | SUPPL-1 | Efficacy |
Label is not available on this site. |