Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074550
Company: ACCORD HLTHCARE
Company: ACCORD HLTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GLIPIZIDE | GLIPIZIDE | 5MG | TABLET;ORAL | Discontinued | None | No | No |
GLIPIZIDE | GLIPIZIDE | 10MG | 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 |
---|---|---|---|---|---|---|---|
09/11/1997 | 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 |
---|---|---|---|---|---|
03/22/2017 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
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08/10/2015 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
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07/28/2011 | SUPPL-8 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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11/18/2010 | SUPPL-6 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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05/08/2002 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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05/08/2002 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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08/15/2001 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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01/28/2000 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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07/07/1999 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |