Drugs@FDA: FDA Approved Drug Products

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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 Prescription AB Yes No
GLUCOTROL GLIPIZIDE 10MG TABLET;ORAL Prescription AB Yes Yes
GLUCOTROL GLIPIZIDE 2.5MG TABLET;ORAL Discontinued None 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
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

GLUCOTROL

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 INC
GLIPIZIDE GLIPIZIDE 5MG TABLET;ORAL Prescription No AB 075795 APOTEX
GLIPIZIDE GLIPIZIDE 5MG TABLET;ORAL Prescription No AB 074226 MYLAN
GLIPIZIDE GLIPIZIDE 5MG TABLET;ORAL Prescription No AB 074438 MYLAN
GLIPIZIDE GLIPIZIDE 5MG TABLET;ORAL Prescription No AB 074305 SANDOZ
GLIPIZIDE GLIPIZIDE 5MG TABLET;ORAL Prescription No AB 077820 SUN PHARM INDS INC
GLIPIZIDE GLIPIZIDE 5MG TABLET;ORAL Prescription No AB 074223 WATSON LABS TEVA
GLUCOTROL GLIPIZIDE 5MG TABLET;ORAL Prescription Yes AB 017783 PFIZER

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 INC
GLIPIZIDE GLIPIZIDE 10MG TABLET;ORAL Prescription No AB 075795 APOTEX
GLIPIZIDE GLIPIZIDE 10MG TABLET;ORAL Prescription No AB 074226 MYLAN
GLIPIZIDE GLIPIZIDE 10MG TABLET;ORAL Prescription No AB 074438 MYLAN
GLIPIZIDE GLIPIZIDE 10MG TABLET;ORAL Prescription No AB 074305 SANDOZ
GLIPIZIDE GLIPIZIDE 10MG TABLET;ORAL Prescription No AB 077820 SUN PHARM INDS INC
GLIPIZIDE GLIPIZIDE 10MG TABLET;ORAL Prescription No AB 074223 WATSON LABS TEVA
GLUCOTROL GLIPIZIDE 10MG TABLET;ORAL Prescription Yes AB 017783 PFIZER

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