Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020055
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GLYBURIDE (MICRONIZED) | GLYBURIDE | 1.5MG | TABLET;ORAL | Discontinued | None | No | No |
| GLYBURIDE (MICRONIZED) | GLYBURIDE | 3MG | TABLET;ORAL | Discontinued | None | No | No |
| GLYBURIDE (MICRONIZED) | GLYBURIDE | 6MG | 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 |
|---|---|---|---|---|---|---|---|
| 04/17/1992 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/08/2000 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/05/1999 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 12/04/1998 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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| 12/24/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/13/1997 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 02/01/1995 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 02/07/1995 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |