Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075890
Company: HIKMA
Company: HIKMA
| 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 |
|---|---|---|---|---|---|---|---|
| 07/31/2003 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75890.ta.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/30/2019 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/05/2016 | SUPPL-8 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/05/2016 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/13/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/13/2015 | SUPPL-5 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 04/13/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/29/2011 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/12/2009 | SUPPL-2 | Labeling |
Label is not available on this site. |