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| HYDERGINE | ERGOLOID MESYLATES | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| HYDERGINE | ERGOLOID MESYLATES | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |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 |
|---|---|---|---|---|---|---|---|
| 12/30/1977 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
|---|---|---|---|---|---|
| 04/02/2001 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/01/2000 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/10/2000 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/13/2000 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/18/1996 | SUPPL-31 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/07/1995 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/12/1995 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/12/1998 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 09/14/1993 | SUPPL-26 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 02/28/1994 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/28/1994 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/07/1989 | SUPPL-20 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 05/26/1987 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/07/1985 | SUPPL-17 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 10/26/1983 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 02/03/1983 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 09/15/1982 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/19/1983 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/25/1982 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 08/10/1981 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/02/1981 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/03/1981 | SUPPL-7 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 12/11/1979 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/04/1981 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 04/05/1979 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/01/1979 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/30/1978 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |