Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074591
Company: STRIDES PHARMA
Company: STRIDES PHARMA
| 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 | 4.5MG | 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 |
|---|---|---|---|---|---|---|---|
| 12/22/1997 | 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 |
|---|---|---|---|---|---|
| 03/23/2021 | SUPPL-11 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
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| 03/23/2021 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/18/2015 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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| 08/27/2001 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |