NDA 020055

SANOFI AVENTIS US

FDA Drug Application

Application #020055

Application Sponsors

NDA 020055

SANOFI AVENTIS US

Marketing Status

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

Application Products

001	TABLET;ORAL	1.5MG	0	GLYBURIDE (MICRONIZED)	GLYBURIDE
002	TABLET;ORAL	3MG	0	GLYBURIDE (MICRONIZED)	GLYBURIDE
003	TABLET;ORAL	6MG	0	GLYBURIDE (MICRONIZED)	GLYBURIDE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1992-04-17	STANDARD
LABELING; Labeling	SUPPL	2	AP	1995-02-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1997-05-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1997-12-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1998-12-04	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1999-02-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2000-03-08	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	7	Null	0

CDER Filings

SANOFI AVENTIS US

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20055
            [companyName] => SANOFI AVENTIS US
            [docInserts] => ["",""]
            [products] => [{"drugName":"GLYBURIDE (MICRONIZED)","activeIngredients":"GLYBURIDE","strength":"1.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GLYBURIDE (MICRONIZED)","activeIngredients":"GLYBURIDE","strength":"3MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"GLYBURIDE (MICRONIZED)","activeIngredients":"GLYBURIDE","strength":"6MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"GLYBURIDE (MICRONIZED)","submission":"GLYBURIDE","actionType":"1.5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GLYBURIDE (MICRONIZED)","submission":"GLYBURIDE","actionType":"3MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"GLYBURIDE (MICRONIZED)","submission":"GLYBURIDE","actionType":"6MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)