Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086188
Company: WATSON LABS
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GERIMAL | ERGOLOID MESYLATES | 1MG | 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-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/25/1988 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 09/02/1988 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 07/18/1988 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/30/1986 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/30/1986 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/30/1986 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/06/1985 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/06/1985 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/06/1985 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/16/1984 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |