NDA 017063

ALCON

FDA Drug Application

Application #017063

Application Sponsors

NDA 017063

ALCON

Marketing Status

• Discontinued: 001

Application Products

001

SOLUTION;ORAL

100GM/220ML

0

ISMOTIC

ISOSORBIDE

FDA Submissions

TYPE 2; Type 2 - New Active Ingredient	ORIG	1	AP	1974-01-30	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1975-08-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1978-06-12	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1980-01-09	STANDARD
LABELING; Labeling	SUPPL	6	AP	1980-12-10
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	1981-04-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1988-03-04	STANDARD
LABELING; Labeling	SUPPL	9	AP	1993-07-13
LABELING; Labeling	SUPPL	11	AP	1998-05-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1999-04-07	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	4	Null	0
SUPPL	5	Null	0
SUPPL	7	Null	0
SUPPL	8	Null	0
SUPPL	12	Null	0

CDER Filings

ALCON

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 17063
            [companyName] => ALCON
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISMOTIC","activeIngredients":"ISOSORBIDE","strength":"100GM\/220ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISMOTIC","submission":"ISOSORBIDE","actionType":"100GM\/220ML","submissionClassification":"SOLUTION;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)