Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018706
Company: NOVARTIS
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| HYDERGINE LC | ERGOLOID MESYLATES | 1MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 01/18/1983 | 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 |
|---|---|---|---|---|---|
| 04/03/2001 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/09/2001 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/10/2000 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/18/1999 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/21/1999 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 12/07/1995 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/16/1994 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/12/1998 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 04/15/1993 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/02/1993 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 02/28/1994 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/07/1989 | SUPPL-12 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 02/09/1989 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 05/26/1987 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/03/1985 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 09/20/1983 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 06/26/1986 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/07/1983 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |