Drugs@FDA: FDA-Approved Drugs
Company: TEVA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GLYBURIDE | GLYBURIDE | 1.25MG | TABLET;ORAL | Prescription | AB1 | No | No |
| GLYBURIDE | GLYBURIDE | 2.5MG | TABLET;ORAL | Prescription | AB1 | No | No |
| GLYBURIDE | GLYBURIDE | 5MG | TABLET;ORAL | Prescription | AB1 | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 08/29/1995 | 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 |
|---|---|---|---|---|---|
| 09/03/2015 | SUPPL-46 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/16/2015 | SUPPL-43 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/23/2014 | SUPPL-41 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/23/2010 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/23/2010 | SUPPL-36 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/11/2014 | SUPPL-35 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 05/01/2009 | SUPPL-32 | Labeling |
Label is not available on this site. |
||
| 09/11/2012 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 01/23/2014 | SUPPL-30 | Labeling |
Label is not available on this site. |
||
| 01/15/2009 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 02/26/2002 | SUPPL-17 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/18/2001 | SUPPL-16 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/20/2000 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 06/26/2000 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/26/2000 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/23/1999 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/04/1999 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/02/1998 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 06/08/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/02/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/15/1997 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 02/02/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/27/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/27/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
GLYBURIDE
TABLET;ORAL; 1.25MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GLYBURIDE | GLYBURIDE | 1.25MG | TABLET;ORAL | Prescription | No | AB1 | 203379 | CADILA PHARMS LTD |
| GLYBURIDE | GLYBURIDE | 1.25MG | TABLET;ORAL | Prescription | No | AB1 | 076257 | EPIC PHARMA LLC |
| GLYBURIDE | GLYBURIDE | 1.25MG | TABLET;ORAL | Prescription | No | AB1 | 090937 | HERITAGE PHARMS |
| GLYBURIDE | GLYBURIDE | 1.25MG | TABLET;ORAL | Prescription | No | AB1 | 206483 | ORIENT PHARMA CO LTD |
| GLYBURIDE | GLYBURIDE | 1.25MG | TABLET;ORAL | Prescription | No | AB1 | 074388 | TEVA |
| GLYBURIDE | GLYBURIDE | 1.25mg | TABLET;ORAL | Prescription | No | AB1 | 206749 | ZYDUS PHARMS |
TABLET;ORAL; 2.5MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GLYBURIDE | GLYBURIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB1 | 203379 | CADILA PHARMS LTD |
| GLYBURIDE | GLYBURIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB1 | 076257 | EPIC PHARMA LLC |
| GLYBURIDE | GLYBURIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB1 | 090937 | HERITAGE PHARMS |
| GLYBURIDE | GLYBURIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB1 | 206483 | ORIENT PHARMA CO LTD |
| GLYBURIDE | GLYBURIDE | 2.5MG | TABLET;ORAL | Prescription | No | AB1 | 074388 | TEVA |
| GLYBURIDE | GLYBURIDE | 2.5mg | TABLET;ORAL | Prescription | No | AB1 | 206749 | ZYDUS PHARMS |
TABLET;ORAL; 5MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GLYBURIDE | GLYBURIDE | 5MG | TABLET;ORAL | Prescription | No | AB1 | 203379 | CADILA PHARMS LTD |
| GLYBURIDE | GLYBURIDE | 5MG | TABLET;ORAL | Prescription | No | AB1 | 076257 | EPIC PHARMA LLC |
| GLYBURIDE | GLYBURIDE | 5MG | TABLET;ORAL | Prescription | No | AB1 | 090937 | HERITAGE PHARMS |
| GLYBURIDE | GLYBURIDE | 5MG | TABLET;ORAL | Prescription | No | AB1 | 206483 | ORIENT PHARMA CO LTD |
| GLYBURIDE | GLYBURIDE | 5MG | TABLET;ORAL | Prescription | No | AB1 | 074388 | TEVA |
| GLYBURIDE | GLYBURIDE | 5MG | TABLET;ORAL | Prescription | No | AB1 | 206749 | ZYDUS PHARMS |