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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017498
Company: PFIZER

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MICRONASE GLYBURIDE 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No
MICRONASE GLYBURIDE 2.5MG TABLET;ORAL Discontinued None No No
MICRONASE GLYBURIDE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET;ORAL Discontinued None Yes No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
05/01/1984 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
05/22/2015 SUPPL-32 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017498s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/017498Orig1s032ltr.pdf
10/15/2013 SUPPL-31 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017498s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017498Orig1s031ltr.pdf
02/01/2011 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017498s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/017498s030ltr.pdf
08/27/2009 SUPPL-29 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017498s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017498s029ltr.pdf
10/27/2008 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017498s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/017498s027ltr.pdf
11/30/1999 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.
10/28/1999 SUPPL-21 Labeling

Label is not available on this site.
06/27/1997 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
04/02/1997 SUPPL-19 Labeling

Label is not available on this site.
04/02/1997 SUPPL-18 Labeling

Label is not available on this site.
09/28/1995 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.
09/28/1995 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.
01/21/1993 SUPPL-14 Labeling

Label is not available on this site.
07/27/1992 SUPPL-13 Labeling

Label is not available on this site.
12/14/1990 SUPPL-12 Labeling

Label is not available on this site.
11/15/1991 SUPPL-11 Manufacturing (CMC)-Control

Label is not available on this site.
04/27/1988 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.
01/05/1988 SUPPL-9 Labeling

Label is not available on this site.
03/02/1988 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.
06/25/1987 SUPPL-7 Labeling

Label is not available on this site.
04/07/1987 SUPPL-6 Labeling

Label is not available on this site.
03/24/1986 SUPPL-5 Labeling

Label is not available on this site.
03/18/1986 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.
07/24/1985 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.
01/15/1985 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
05/22/2015 SUPPL-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/017498s032lbl.pdf
10/15/2013 SUPPL-31 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017498s031lbl.pdf
02/01/2011 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/017498s030lbl.pdf
08/27/2009 SUPPL-29 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017498s029lbl.pdf
10/27/2008 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/017498s027lbl.pdf
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