Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084294
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CAFERGOT | CAFFEINE; ERGOTAMINE TARTRATE | 100MG;1MG | TABLET;ORAL | Discontinued | None | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 09/29/1976 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/14/2008 | SUPPL-83 | Labeling |
Label is not available on this site. |
||
| 10/03/2003 | SUPPL-75 | Labeling |
Label is not available on this site. |
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| 07/26/1999 | SUPPL-72 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/24/1994 | SUPPL-71 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/1987 | SUPPL-70 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/03/1987 | SUPPL-69 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/05/1986 | SUPPL-68 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/17/1984 | SUPPL-67 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/26/1984 | SUPPL-66 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/03/1984 | SUPPL-65 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/03/1984 | SUPPL-64 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/09/1983 | SUPPL-63 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/18/1983 | SUPPL-61 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/06/1983 | SUPPL-60 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/24/1983 | SUPPL-58 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/01/1982 | SUPPL-53 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/01/1982 | SUPPL-52 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/01/1982 | SUPPL-51 | Manufacturing (CMC) |
Label is not available on this site. |