Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021460
Company: BRISTOL MYERS SQUIBB
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GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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GLIPIZIDE; METFORMIN HYDROCHLORIDE 2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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GLIPIZIDE; METFORMIN HYDROCHLORIDE 5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
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
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

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