Drugs@FDA: FDA-Approved Drugs
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDERGINE | ERGOLOID MESYLATES | 1MG | TABLET;SUBLINGUAL | Discontinued | None | No | No |
| HYDERGINE | ERGOLOID MESYLATES | 0.5MG | TABLET;SUBLINGUAL | 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 |
|---|---|---|---|---|---|---|---|
| 11/05/1953 | 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 |
|---|---|---|---|---|---|
| 05/10/2000 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/21/1999 | SUPPL-46 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 11/12/1998 | SUPPL-45 | Labeling |
Label is not available on this site. |
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| 09/14/1993 | SUPPL-44 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 04/06/1993 | SUPPL-41 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/07/1989 | SUPPL-39 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 05/26/1987 | SUPPL-38 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 10/26/1983 | SUPPL-36 | Labeling |
Label is not available on this site. |
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| 08/26/1983 | SUPPL-35 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/03/1983 | SUPPL-33 | Labeling |
Label is not available on this site. |
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| 01/19/1983 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/10/1981 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/02/1981 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/19/1981 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 02/24/1981 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/11/1979 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/14/1979 | SUPPL-25 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 02/04/1981 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 07/13/1978 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/16/1978 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/27/1978 | SUPPL-20 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 04/14/1978 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 03/20/1978 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/28/1976 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/30/1976 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/23/1976 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/13/1975 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/06/1975 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 06/25/1975 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/02/1975 | SUPPL-6 | Efficacy |
Label is not available on this site. |
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| 12/13/1974 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/16/1975 | SUPPL-4 | Unspecified |
Label is not available on this site. |
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| 06/25/1974 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |