Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020329
Company: PFIZER
Company: PFIZER
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| GLUCOTROL XL | GLIPIZIDE | 5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | No |
| GLUCOTROL XL | GLIPIZIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | Yes |
| GLUCOTROL XL | GLIPIZIDE | 2.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | AB | Yes | 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 |
|---|---|---|---|---|---|---|---|
| 04/26/1994 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/03/2021 | SUPPL-35 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020329Orig1s035lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020329Orig1s035ltr.pdf | |
| 08/10/2018 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020329s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/020329Orig1s032ltr.pdf | |
| 08/16/2017 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020329s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020329Orig1s030ltr.pdf | |
| 10/05/2015 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020329s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020329Orig1s029ltr.pdf | |
| 10/15/2013 | SUPPL-28 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020329s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020329Orig1s028ltr.pdf | |
| 02/07/2011 | SUPPL-25 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020329s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020329s025ltr.pdf | |
| 08/31/2009 | SUPPL-24 | Labeling |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020329s024lbl.pdf | |
| 10/27/2008 | SUPPL-22 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020329s22lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020329s022ltr.pdf | |
| 09/17/2003 | SUPPL-15 | Labeling |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20329slr015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020329_S015_GLUCOTROL XP_AP.pdf |
| 10/26/2001 | SUPPL-13 | Labeling |
Label is not available on this site. |
||
| 06/25/2001 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/31/2000 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/16/2001 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/2000 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/26/2000 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/17/2000 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/05/2001 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 12/15/1999 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/18/1999 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/10/1999 | SUPPL-3 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020329_S003_Glucotrol XL_APPROVAL PACKAGES.pdf |
| 04/01/2002 | SUPPL-2 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20329s2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20329s002ltr.pdf | |
| 02/04/1998 | SUPPL-1 | Efficacy-New Indication |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/03/2021 | SUPPL-35 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020329Orig1s035lbl.pdf | |
| 08/10/2018 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/020329s032lbl.pdf | |
| 08/16/2017 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020329s030lbl.pdf | |
| 10/05/2015 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020329s029lbl.pdf | |
| 10/15/2013 | SUPPL-28 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020329s028lbl.pdf | |
| 02/07/2011 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020329s025lbl.pdf | |
| 08/31/2009 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020329s024lbl.pdf | |
| 10/27/2008 | SUPPL-22 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020329s22lbl.pdf | |
| 04/01/2002 | SUPPL-2 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20329s2lbl.pdf |
GLUCOTROL XL
TABLET, EXTENDED RELEASE;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, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206928 | AUROBINDO PHARMA |
| GLIPIZIDE | GLIPIZIDE | 5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204720 | UNIQUE |
| GLIPIZIDE | GLIPIZIDE | 5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076467 | WATSON LABS |
| GLIPIZIDE | GLIPIZIDE | 5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203499 | ZYDUS PHARMS |
| GLUCOTROL XL | GLIPIZIDE | 5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020329 | PFIZER |
TABLET, EXTENDED RELEASE;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, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206928 | AUROBINDO PHARMA |
| GLIPIZIDE | GLIPIZIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204720 | UNIQUE |
| GLIPIZIDE | GLIPIZIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076467 | WATSON LABS |
| GLIPIZIDE | GLIPIZIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203499 | ZYDUS PHARMS |
| GLUCOTROL XL | GLIPIZIDE | 10MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020329 | PFIZER |
TABLET, EXTENDED RELEASE;ORAL; 2.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| GLIPIZIDE | GLIPIZIDE | 2.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 206928 | AUROBINDO PHARMA |
| GLIPIZIDE | GLIPIZIDE | 2.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 204720 | UNIQUE |
| GLIPIZIDE | GLIPIZIDE | 2.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 076467 | WATSON LABS |
| GLIPIZIDE | GLIPIZIDE | 2.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 203499 | ZYDUS PHARMS |
| GLUCOTROL XL | GLIPIZIDE | 2.5MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | Yes | AB | 020329 | PFIZER |