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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017783
Company: PFIZER

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GLUCOTROL GLIPIZIDE 5MG TABLET;ORAL Discontinued None Yes No
GLUCOTROL GLIPIZIDE 10MG TABLET;ORAL Discontinued None Yes No
GLUCOTROL GLIPIZIDE 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No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
05/08/1984 ORIG-1 Approval Type 1 - New Molecular Entity 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
08/18/2016 SUPPL-26 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017783s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/017783Orig1s026ltr.pdf
10/15/2013 SUPPL-25 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017783s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017783Orig1s025ltr.pdf
02/07/2011 SUPPL-21 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017783s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017783s021ltr.pdf
08/27/2009 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017783s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017783s020ltr.pdf
10/27/2008 SUPPL-19 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017783s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017783s019ltr.pdf
12/15/1999 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.
08/06/1999 SUPPL-15 Labeling

Label is not available on this site.
12/11/1997 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.
11/24/1993 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
05/19/1993 SUPPL-12 Labeling

Label is not available on this site.
05/11/1993 SUPPL-11 Manufacturing (CMC)-Formulation

Label is not available on this site.
08/06/1991 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.
05/14/1987 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
03/31/1987 SUPPL-8 Labeling

Label is not available on this site.
09/15/1986 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.
03/04/1987 SUPPL-6 Manufacturing (CMC)-Packaging

Label is not available on this site.
10/16/1985 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
11/18/1985 SUPPL-4 Labeling

Label is not available on this site.
10/22/1985 SUPPL-3 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
03/15/1985 SUPPL-2 Manufacturing (CMC)-Formulation

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
08/18/2016 SUPPL-26 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017783s026lbl.pdf
10/15/2013 SUPPL-25 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017783s025lbl.pdf
02/07/2011 SUPPL-21 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017783s021lbl.pdf
08/27/2009 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017783s020lbl.pdf
10/27/2008 SUPPL-19 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017783s019lbl.pdf
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