Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021178
Company: BRISTOL MYERS SQUIBB
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
GLUCOVANCE GLYBURIDE; METFORMIN HYDROCHLORIDE 1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
GLUCOVANCE GLYBURIDE; METFORMIN HYDROCHLORIDE 2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No
GLUCOVANCE GLYBURIDE; METFORMIN HYDROCHLORIDE 5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
07/31/2000 ORIG-1 Approval Type 3 - New Dosage Form and Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21178lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21178ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-178_Glucovance.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/27/2018 SUPPL-18 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021178s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021178Orig1s018ltr.pdf
04/05/2017 SUPPL-17 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021178s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021178Orig1s016s017ltr.pdf
04/05/2017 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021178s016s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021178Orig1s016s017ltr.pdf
10/15/2013 SUPPL-15 Labeling-Package Insert, Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021178s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021178Orig1s015ltr.pdf
08/15/2013 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

03/14/2013 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

11/24/2010 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021178s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021178s012ltr.pdf
11/24/2009 SUPPL-11 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021178s011lbl.pdf
09/16/2008 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021178s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021178s010ltr.pdf
12/14/2006 SUPPL-9 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021178s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021178s009ltr.pdf
03/15/2004 SUPPL-7 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21178se5-007_glucovance_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21178se5-007ltr.pdf
07/02/2002 SUPPL-5 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

09/30/2002 SUPPL-4 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21178s4lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21178se1-004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-178S004_Glucovance.cfm
07/08/2002 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

02/28/2001 SUPPL-2 Labeling

Label is not available on this site.

12/13/2000 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/27/2018 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021178s018lbl.pdf
04/05/2017 SUPPL-17 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021178s016s017lbl.pdf
04/05/2017 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021178s016s017lbl.pdf
10/15/2013 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021178s015lbl.pdf
10/15/2013 SUPPL-15 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021178s015lbl.pdf
11/24/2010 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021178s012lbl.pdf
11/24/2009 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021178s011lbl.pdf
09/16/2008 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021178s010lbl.pdf
12/14/2006 SUPPL-9 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021178s009lbl.pdf
03/15/2004 SUPPL-7 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21178se5-007_glucovance_lbl.pdf
09/30/2002 SUPPL-4 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21178s4lbl.pdf
07/31/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21178lbl.pdf

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