Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087693
Company: PANGEA
Company: PANGEA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ERGOMAR | ERGOTAMINE TARTRATE | 2MG | TABLET;SUBLINGUAL | Prescription | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 09/25/1992 | ORIG-1 | Approval |
ANDA 087693 was approved on 02/24/1983.
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/07/2009 | SUPPL-29 | Labeling |
Label is not available on this site. |
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| 10/20/2003 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 06/30/1995 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 06/30/1995 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/14/1990 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/14/1988 | SUPPL-13 | Bioequivalence |
Label is not available on this site. |
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| 06/30/1989 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 06/30/1992 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/30/1989 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/09/1987 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/09/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/18/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/18/1985 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |