An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 021460
Company: BRISTOL MYERS SQUIBB

Products on NDA 021460

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
METAGLIP	GLIPIZIDE; METFORMIN HYDROCHLORIDE	2.5MG;250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
METAGLIP	GLIPIZIDE; METFORMIN HYDROCHLORIDE	2.5MG;500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No
METAGLIP	GLIPIZIDE; METFORMIN HYDROCHLORIDE	5MG;500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;ORAL	Discontinued	None	Yes	No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 021460

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/21/2002	ORIG-1	Approval	Type 4 - New Combination	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21460lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21460ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021460_metaglip.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/15/2013	SUPPL-10	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021460s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021460Orig1s010ltr.pdf
02/01/2011	SUPPL-9	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021460s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021460s009ltr.pdf
08/07/2009	SUPPL-8	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021460s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021460s008ltr.pdf
08/18/2008	SUPPL-7	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021460s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021460s007ltr.pdf
06/18/2007	SUPPL-5	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021460s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021460s005ltr.pdf

Labels for NDA 021460

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/15/2013	SUPPL-10	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021460s010lbl.pdf
02/01/2011	SUPPL-9	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021460s009lbl.pdf
08/07/2009	SUPPL-8	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021460s008lbl.pdf
08/18/2008	SUPPL-7	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021460s007lbl.pdf
06/18/2007	SUPPL-5	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021460s005lbl.pdf
10/21/2002	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21460lbl.pdf

Top