Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074497
Company: ANI PHARMS
Company: ANI PHARMS
| 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 |
|---|---|---|---|---|---|---|---|
| 08/31/1995 | 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 |
|---|---|---|---|---|---|
| 12/20/2019 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/20/2019 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/25/2011 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/27/2010 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/11/2009 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 04/25/2008 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 07/29/2002 | SUPPL-7 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 04/29/2002 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/12/2001 | SUPPL-5 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/31/2000 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 05/31/2000 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/28/2000 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 10/20/1998 | SUPPL-1 | Manufacturing (CMC) |
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 |