NDA 021460

BRISTOL MYERS SQUIBB

FDA Drug Application

Application #021460

Documents

• Letter: 2002-10-21
• Letter: 2013-10-16
• Label: 2011-02-04
• Letter: 2007-07-05
• Letter: 2008-08-20
• Letter: 2009-11-25
• Letter: 2011-02-03
• Label: 2002-10-21
• Label: 2007-06-27
• Label: 2008-08-26
• Label: 2009-09-18
• Label: 2013-10-22
• Review: 2003-04-30

Application Sponsors

NDA 021460

BRISTOL MYERS SQUIBB

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET;ORAL	2.5MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	METAGLIP	GLIPIZIDE; METFORMIN HYDROCHLORIDE
002	TABLET;ORAL	2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	METAGLIP	GLIPIZIDE; METFORMIN HYDROCHLORIDE
003	TABLET;ORAL	5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	METAGLIP	GLIPIZIDE; METFORMIN HYDROCHLORIDE

FDA Submissions

TYPE 4; Type 4 - New Combination	ORIG	1	AP	2002-10-21	STANDARD
LABELING; Labeling	SUPPL	5	AP	2007-06-18	STANDARD
LABELING; Labeling	SUPPL	7	AP	2008-08-18	STANDARD
LABELING; Labeling	SUPPL	8	AP	2009-08-07	STANDARD
LABELING; Labeling	SUPPL	9	AP	2011-02-01	STANDARD
LABELING; Labeling	SUPPL	10	AP	2013-10-15	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0

CDER Filings

BRISTOL MYERS SQUIBB

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 21460
            [companyName] => BRISTOL MYERS SQUIBB
            [docInserts] => ["",""]
            [products] => [{"drugName":"METAGLIP","activeIngredients":"GLIPIZIDE; METFORMIN HYDROCHLORIDE","strength":"2.5MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"METAGLIP","activeIngredients":"GLIPIZIDE; METFORMIN HYDROCHLORIDE","strength":"2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"METAGLIP","activeIngredients":"GLIPIZIDE; METFORMIN HYDROCHLORIDE","strength":"5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"10\/15\/2013","submission":"SUPPL-10","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/021460s010lbl.pdf\"}]","notes":""},{"actionDate":"02\/01\/2011","submission":"SUPPL-9","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/021460s009lbl.pdf\"}]","notes":""},{"actionDate":"08\/07\/2009","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/021460s008lbl.pdf\"}]","notes":""},{"actionDate":"08\/18\/2008","submission":"SUPPL-7","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/021460s007lbl.pdf\"}]","notes":""},{"actionDate":"06\/18\/2007","submission":"SUPPL-5","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2007\\\/021460s005lbl.pdf\"}]","notes":""},{"actionDate":"10\/21\/2002","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2002\\\/21460lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"METAGLIP","submission":"GLIPIZIDE; METFORMIN HYDROCHLORIDE","actionType":"2.5MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"METAGLIP","submission":"GLIPIZIDE; METFORMIN HYDROCHLORIDE","actionType":"2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"METAGLIP","submission":"GLIPIZIDE; METFORMIN HYDROCHLORIDE","actionType":"5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2013-10-15
        )

)