Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086189
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GERIMAL | ERGOLOID MESYLATES | 0.5MG | TABLET;SUBLINGUAL | 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 |
|---|---|---|---|---|---|---|---|
| 07/07/1980 | 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 |
|---|---|---|---|---|---|
| 01/31/1997 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/25/1988 | SUPPL-23 | Labeling |
Label is not available on this site. |
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| 09/01/1988 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 07/18/1988 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/30/1986 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/30/1986 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/30/1986 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/05/1985 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/05/1985 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/05/1985 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/30/1985 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |