Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078599
Company: HIKMA PHARMS
Company: HIKMA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GEMFIBROZIL | GEMFIBROZIL | 600MG | TABLET;ORAL | 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 |
---|---|---|---|---|---|---|---|
08/16/2010 | 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 |
---|---|---|---|---|---|
11/28/2022 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
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06/22/2020 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
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11/09/2010 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |