NDA 020682

PHARMACIA AND UPJOHN

FDA Drug Application

Application #020682

Documents

• Letter: 1999-08-16
• Label: 2012-09-17
• Letter: 2009-05-04
• Letter: 2012-09-20
• Label: 2009-05-13
• Review: 1999-08-16
• Review: 2019-02-15

Application Sponsors

NDA 020682

PHARMACIA AND UPJOHN

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	TABLET;ORAL	25MG	1	GLYSET	MIGLITOL
002	TABLET;ORAL	50MG	1	GLYSET	MIGLITOL
003	TABLET;ORAL	100MG	1	GLYSET	MIGLITOL

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1996-12-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1999-04-06	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1998-12-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1999-09-29	STANDARD
LABELING; Labeling	SUPPL	8	AP	2009-04-24	STANDARD
LABELING; Labeling	SUPPL	10	AP	2012-09-17	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2015-10-14	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	10	Null	7
SUPPL	12	Null	0

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

PFIZER

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20682
            [companyName] => PFIZER
            [docInserts] => ["",""]
            [products] => [{"drugName":"GLYSET","activeIngredients":"MIGLITOL","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"GLYSET","activeIngredients":"MIGLITOL","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"},{"drugName":"GLYSET","activeIngredients":"MIGLITOL","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"09\/17\/2012","submission":"SUPPL-10","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2012\\\/020682s010lbl.pdf\"}]","notes":""},{"actionDate":"04\/24\/2009","submission":"SUPPL-8","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020682s008lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"GLYSET","submission":"MIGLITOL","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"GLYSET","submission":"MIGLITOL","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"GLYSET","submission":"MIGLITOL","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2012-09-17
        )

)