NDA 020051

PHARMACIA AND UPJOHN

FDA Drug Application

Application #020051

Documents

• Letter: 2008-11-03
• Letter: 2009-11-19
• Letter: 2011-02-09
• Letter: 2015-05-26
• Review: 1997-01-10
• Letter: 2013-10-16
• Label: 2008-11-07
• Label: 2009-09-17
• Label: 2011-02-07
• Label: 2013-10-22
• Label: 2015-05-27
• Label: 2017-08-24
• Letter: 2017-08-29

Application Sponsors

NDA 020051

PHARMACIA AND UPJOHN

Marketing Status

• Prescription: 001
• Prescription: 002
• Discontinued: 003
• Prescription: 004

Application Products

001	TABLET;ORAL	1.5MG	1	GLYNASE	GLYBURIDE
002	TABLET;ORAL	3MG	1	GLYNASE	GLYBURIDE
003	TABLET;ORAL	4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**	1	GLYNASE	GLYBURIDE
004	TABLET;ORAL	6MG	1	GLYNASE	GLYBURIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1992-03-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1993-09-24	STANDARD
LABELING; Labeling	SUPPL	3	AP	1993-01-21	STANDARD
LABELING; Labeling	SUPPL	4	AP	1996-02-21	STANDARD
LABELING; Labeling	SUPPL	7	AP	1997-04-18	STANDARD
LABELING; Labeling	SUPPL	8	AP	1997-01-10	STANDARD
LABELING; Labeling	SUPPL	9	AP	1999-10-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1999-11-30	STANDARD
LABELING; Labeling	SUPPL	13	AP	2008-10-29	STANDARD
LABELING; Labeling	SUPPL	16	AP	2009-08-27	STANDARD
LABELING; Labeling	SUPPL	17	AP	2011-02-07	UNKNOWN
LABELING; Labeling	SUPPL	20	AP	2013-10-15	STANDARD
LABELING; Labeling	SUPPL	21	AP	2015-05-22	STANDARD
LABELING; Labeling	SUPPL	22	AP	2017-08-22	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	10	Null	0
SUPPL	16	Null	7
SUPPL	17	Null	6
SUPPL	20	Null	7
SUPPL	21	Null	15
SUPPL	22	Null	6

TE Codes

001	Prescription	AB
002	Prescription	AB
004	Prescription	AB

CDER Filings

PFIZER

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20051
            [companyName] => PFIZER
            [docInserts] => ["",""]
            [products] => [{"drugName":"GLYNASE","activeIngredients":"GLYBURIDE","strength":"1.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"GLYNASE","activeIngredients":"GLYBURIDE","strength":"3MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"GLYNASE","activeIngredients":"GLYBURIDE","strength":"4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"GLYNASE","activeIngredients":"GLYBURIDE","strength":"6MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/22\/2017","submission":"SUPPL-22","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020051s022lbl.pdf\"}]","notes":""},{"actionDate":"08\/22\/2017","submission":"SUPPL-22","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/020051s022lbl.pdf\"}]","notes":""},{"actionDate":"05\/22\/2015","submission":"SUPPL-21","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/020051s021lbl.pdf\"}]","notes":""},{"actionDate":"10\/15\/2013","submission":"SUPPL-20","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2013\\\/020051s020lbl.pdf\"}]","notes":""},{"actionDate":"02\/07\/2011","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020051s017lbl.pdf\"}]","notes":""},{"actionDate":"08\/27\/2009","submission":"SUPPL-16","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020051s016lbl.pdf\"}]","notes":""},{"actionDate":"10\/29\/2008","submission":"SUPPL-13","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2008\\\/020051s013lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"GLYNASE","submission":"GLYBURIDE","actionType":"1.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"GLYNASE","submission":"GLYBURIDE","actionType":"3MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"GLYNASE","submission":"GLYBURIDE","actionType":"4.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">Yes"},{"actionDate":"GLYNASE","submission":"GLYBURIDE","actionType":"6MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2017-08-22
        )

)