Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018418
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDERGINE | ERGOLOID MESYLATES | 1MG/ML | SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 01/30/1981 | 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 |
|---|---|---|---|---|---|
| 05/10/2000 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/12/1998 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 02/28/1994 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/26/1987 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/27/1987 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 09/13/1984 | SUPPL-8 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 10/26/1983 | SUPPL-7 | Labeling |
Label is not available on this site. |
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| 02/03/1983 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 03/24/1983 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 11/23/1982 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |