Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074550
Company: ACCORD HLTHCARE
Company: ACCORD HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GLIPIZIDE | GLIPIZIDE | 5MG | TABLET;ORAL | Prescription | AB | No | No |
| GLIPIZIDE | GLIPIZIDE | 10MG | TABLET;ORAL | Prescription | AB | 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 |
|---|---|---|---|---|---|---|---|
| 09/11/1997 | 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 |
|---|---|---|---|---|---|
| 03/22/2017 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/10/2015 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/28/2011 | SUPPL-8 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/18/2010 | SUPPL-6 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/08/2002 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/08/2002 | SUPPL-4 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/15/2001 | SUPPL-3 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/28/2000 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/07/1999 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
GLIPIZIDE
TABLET;ORAL; 5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GLIPIZIDE | GLIPIZIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 074550 | ACCORD HLTHCARE |
| GLIPIZIDE | GLIPIZIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 074497 | ANI PHARMS |
| GLIPIZIDE | GLIPIZIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 075795 | APOTEX |
| GLIPIZIDE | GLIPIZIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 074226 | AUROBINDO PHARMA USA |
| GLIPIZIDE | GLIPIZIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 214874 | RUBICON |
| GLIPIZIDE | GLIPIZIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 074305 | SANDOZ |
| GLIPIZIDE | GLIPIZIDE | 5MG | TABLET;ORAL | Prescription | No | AB | 074223 | WATSON LABS TEVA |
TABLET;ORAL; 10MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GLIPIZIDE | GLIPIZIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 074550 | ACCORD HLTHCARE |
| GLIPIZIDE | GLIPIZIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 074497 | ANI PHARMS |
| GLIPIZIDE | GLIPIZIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 075795 | APOTEX |
| GLIPIZIDE | GLIPIZIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 074226 | AUROBINDO PHARMA USA |
| GLIPIZIDE | GLIPIZIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 214874 | RUBICON |
| GLIPIZIDE | GLIPIZIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 074305 | SANDOZ |
| GLIPIZIDE | GLIPIZIDE | 10MG | TABLET;ORAL | Prescription | No | AB | 074223 | WATSON LABS TEVA |