Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076159
Company: ENDO OPERATIONS
Company: ENDO OPERATIONS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GLIPIZIDE | GLIPIZIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Discontinued | None | No | No |
GLIPIZIDE | GLIPIZIDE | 5MG | TABLET, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
09/20/2013 | 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 |
---|---|---|---|---|---|
04/14/2020 | SUPPL-10 | Labeling-Container/Carton Labels, Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
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04/14/2020 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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04/14/2020 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |