Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020329
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
08/10/2018 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
08/10/2018 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 LTD
GLIPIZIDE GLIPIZIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076159 PAR PHARM
GLIPIZIDE GLIPIZIDE 5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204720 UNIQUE PHARM LABS
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 LTD
GLIPIZIDE GLIPIZIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 076159 PAR PHARM
GLIPIZIDE GLIPIZIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204720 UNIQUE PHARM LABS
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 LTD
GLIPIZIDE GLIPIZIDE 2.5MG TABLET, EXTENDED RELEASE;ORAL Prescription No AB 204720 UNIQUE PHARM LABS
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

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