Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075795
Company: APOTEX
Company: APOTEX
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 | 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 |
---|---|---|---|---|---|---|---|
06/13/2001 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75795ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/18/2017 | SUPPL-13 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
||
04/26/2016 | SUPPL-12 | Labeling-Patient Package Insert |
Label is not available on this site. |
||
07/26/2013 | SUPPL-11 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
07/26/2013 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
03/25/2009 | SUPPL-8 | Labeling |
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 | 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 | 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 | 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 | 074223 | WATSON LABS TEVA |