Drugs@FDA: FDA-Approved Drugs
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ISMELIN | GUANETHIDINE MONOSULFATE | EQ 10MG SULFATE | TABLET;ORAL | Discontinued | None | No | No |
| ISMELIN | GUANETHIDINE MONOSULFATE | EQ 25MG SULFATE | 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 |
|---|---|---|---|---|---|---|---|
| 07/05/1960 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/22/1986 | SUPPL-54 | Labeling |
Label is not available on this site. |
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| 05/05/1986 | SUPPL-53 | Labeling |
Label is not available on this site. |
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| 05/05/1986 | SUPPL-52 | Labeling |
Label is not available on this site. |
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| 03/19/1985 | SUPPL-51 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/05/1986 | SUPPL-50 | Labeling |
Label is not available on this site. |
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| 02/02/1981 | SUPPL-49 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 12/12/1980 | SUPPL-48 | Labeling |
Label is not available on this site. |
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| 05/08/1980 | SUPPL-47 | Labeling |
Label is not available on this site. |
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| 01/24/1980 | SUPPL-46 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 01/17/1980 | SUPPL-45 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 06/25/1979 | SUPPL-44 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 06/25/1979 | SUPPL-43 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 06/25/1979 | SUPPL-42 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 01/08/1979 | SUPPL-41 | Labeling |
Label is not available on this site. |
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| 01/31/1979 | SUPPL-40 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/12/1979 | SUPPL-39 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 06/29/1977 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/12/1977 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/02/1976 | SUPPL-36 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 12/29/1976 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/03/1976 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/19/1976 | SUPPL-33 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/02/1975 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 03/31/1975 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/31/1975 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 03/31/1975 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 05/15/1975 | SUPPL-26 | Unspecified |
Label is not available on this site. |
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| 09/26/1975 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 05/15/1975 | SUPPL-23 | Unspecified |
Label is not available on this site. |
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| 09/26/1975 | SUPPL-22 | Labeling |
Label is not available on this site. |