Drugs@FDA: FDA-Approved Drugs
Company: TEVA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GLIMEPIRIDE | GLIMEPIRIDE | 1MG | TABLET;ORAL | Discontinued | None | No | No |
GLIMEPIRIDE | GLIMEPIRIDE | 2MG | TABLET;ORAL | Discontinued | None | No | No |
GLIMEPIRIDE | GLIMEPIRIDE | 4MG | 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 |
---|---|---|---|---|---|---|---|
10/06/2005 | ORIG-1 | Approval |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/076802ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/076802Orig1s000.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/31/2019 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
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04/17/2017 | SUPPL-18 | Labeling-Package Insert |
Label is not available on this site. |
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02/29/2016 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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02/29/2016 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
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07/31/2013 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
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11/30/2009 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
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11/30/2009 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
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11/30/2009 | SUPPL-12 | Labeling |
Label is not available on this site. |
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03/23/2012 | SUPPL-11 | Labeling |
Label is not available on this site. |
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12/26/2007 | SUPPL-6 | Labeling |
Label is not available on this site. |
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12/19/2006 | SUPPL-4 | Labeling |
Label is not available on this site. |