NDA 018894

COSETTE

FDA Drug Application

Application #018894

Application Sponsors

NDA 018894

COSETTE

Marketing Status

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

Application Products

001	TABLET;ORAL	100MG	0	TOLAZAMIDE	TOLAZAMIDE
002	TABLET;ORAL	250MG	0	TOLAZAMIDE	TOLAZAMIDE
003	TABLET;ORAL	500MG	0	TOLAZAMIDE	TOLAZAMIDE

FDA Submissions

	ORIG	1	AP	1984-10-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1986-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1986-06-09
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	1986-11-28
LABELING; Labeling	SUPPL	9	AP	1994-06-13
LABELING; Labeling	SUPPL	10	AP	1995-06-30
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1995-12-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1995-12-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1998-08-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	2000-01-28
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	2002-03-12
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	2002-07-29

Submissions Property Types

SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	15	Null	0
SUPPL	16	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0

CDER Filings

COSETTE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 18894
            [companyName] => COSETTE
            [docInserts] => ["",""]
            [products] => [{"drugName":"TOLAZAMIDE","activeIngredients":"TOLAZAMIDE","strength":"100MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TOLAZAMIDE","activeIngredients":"TOLAZAMIDE","strength":"250MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"TOLAZAMIDE","activeIngredients":"TOLAZAMIDE","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"TOLAZAMIDE","submission":"TOLAZAMIDE","actionType":"100MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TOLAZAMIDE","submission":"TOLAZAMIDE","actionType":"250MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"TOLAZAMIDE","submission":"TOLAZAMIDE","actionType":"500MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)