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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 017532
Company: SANOFI AVENTIS US

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DIABETA GLYBURIDE 1.25MG TABLET;ORAL Prescription AB2 Yes No
DIABETA GLYBURIDE 2.5MG TABLET;ORAL Prescription AB2 Yes No
DIABETA GLYBURIDE 5MG TABLET;ORAL Prescription AB2 Yes Yes

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 5 - New Formulation or New Manufacturer 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
01/11/2017 SUPPL-38 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017532s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/017532Orig1s038ltr.pdf
08/25/2014 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.
08/16/2013 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.
10/15/2013 SUPPL-34 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017532Orig1s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017532Orig1s034ltr.pdf
07/09/2009 SUPPL-30 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017532s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017532s030ltr.pdf
03/05/2009 SUPPL-28 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017532s027s028lb.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017532s027,s028ltr.pdf
03/05/2009 SUPPL-27 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017532s027s028lb.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/017532s027,s028ltr.pdf
12/29/1999 SUPPL-23 Labeling

Label is not available on this site.
10/08/1997 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.
02/20/1997 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.
03/29/1996 SUPPL-20 Manufacturing (CMC)-Packaging

Label is not available on this site.
11/22/1996 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.
02/01/1995 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.
08/11/1994 SUPPL-17 Labeling

Label is not available on this site.
05/20/1994 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.
07/27/1993 SUPPL-15 Labeling

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

Label is not available on this site.
03/26/1993 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.
08/06/1992 SUPPL-12 Labeling

Label is not available on this site.
06/19/1992 SUPPL-11 Labeling

Label is not available on this site.
03/26/1993 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.
04/27/1988 SUPPL-9 Labeling

Label is not available on this site.
04/27/1988 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
08/27/1987 SUPPL-7 Labeling

Label is not available on this site.
10/20/1987 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.
10/20/1987 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.
07/01/1986 SUPPL-4 Labeling

Label is not available on this site.
01/04/1985 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.
03/27/1985 SUPPL-2 Manufacturing (CMC)-Formulation

Label is not available on this site.
03/27/1985 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
01/11/2017 SUPPL-38 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/017532s038lbl.pdf
10/15/2013 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017532Orig1s034lbl.pdf
07/09/2009 SUPPL-30 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017532s030lbl.pdf
03/05/2009 SUPPL-28 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017532s027s028lb.pdf
03/05/2009 SUPPL-27 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/017532s027s028lb.pdf

DIABETA

TABLET;ORAL; 1.25MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIABETA GLYBURIDE 1.25MG TABLET;ORAL Prescription Yes AB2 017532 SANOFI AVENTIS US
GLYBURIDE GLYBURIDE 1.25MG TABLET;ORAL Prescription No AB2 206079 IMPAX LABS INC

TABLET;ORAL; 2.5MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIABETA GLYBURIDE 2.5MG TABLET;ORAL Prescription Yes AB2 017532 SANOFI AVENTIS US
GLYBURIDE GLYBURIDE 2.5MG TABLET;ORAL Prescription No AB2 206079 IMPAX LABS INC

TABLET;ORAL; 5MG
TE Code = AB2

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DIABETA GLYBURIDE 5MG TABLET;ORAL Prescription Yes AB2 017532 SANOFI AVENTIS US
GLYBURIDE GLYBURIDE 5MG TABLET;ORAL Prescription No AB2 206079 IMPAX LABS INC
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