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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021178
Company: BRISTOL MYERS SQUIBB

Products on NDA 021178

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GLYBURIDE; METFORMIN HYDROCHLORIDE	1.25MG;250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No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GLYBURIDE; METFORMIN HYDROCHLORIDE	2.5MG;500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No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GLYBURIDE; METFORMIN HYDROCHLORIDE	5MG;500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021178

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.

Labels for NDA 021178

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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