Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086557
Company: COSETTE
Company: COSETTE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MIGERGOT | CAFFEINE; ERGOTAMINE TARTRATE | 100MG;2MG | SUPPOSITORY;RECTAL | Prescription | None | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 10/04/1983 | 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 |
|---|---|---|---|---|---|
| 11/08/2012 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/18/2012 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/01/2003 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 10/19/1999 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 03/12/1999 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/12/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/12/1999 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/20/1987 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |