Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077537
Company: AUROBINDO PHARMA
Company: AUROBINDO PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GLYBURIDE | GLYBURIDE | 1.25MG | TABLET;ORAL | Discontinued | None | No | No |
GLYBURIDE | GLYBURIDE | 2.5MG | TABLET;ORAL | Discontinued | None | No | No |
GLYBURIDE | GLYBURIDE | 5MG | 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 |
---|---|---|---|---|---|---|---|
10/18/2007 | 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 |
---|---|---|---|---|---|
10/06/2015 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
02/25/2015 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
09/28/2012 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
03/20/2009 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
12/31/2008 | SUPPL-3 | Labeling |
Label is not available on this site. |
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