NDA 016192

ASTRAZENECA

FDA Drug Application

Application #016192

Application Sponsors

NDA 016192

ASTRAZENECA

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET;ORAL	5MG	0	SORBITRATE	ISOSORBIDE DINITRATE
002	TABLET;ORAL	10MG	0	SORBITRATE	ISOSORBIDE DINITRATE

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	1968-01-16	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1980-08-05	STANDARD
LABELING; Labeling	SUPPL	25	AP	1981-07-09	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	41	AP	1996-04-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	1996-10-11	STANDARD
LABELING; Labeling	SUPPL	43	AP	1999-01-26	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	22	Null	0
SUPPL	25	Null	0
SUPPL	41	Null	0
SUPPL	42	Null	0
SUPPL	43	Null	0

CDER Filings

ASTRAZENECA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 16192
            [companyName] => ASTRAZENECA
            [docInserts] => ["",""]
            [products] => [{"drugName":"SORBITRATE","activeIngredients":"ISOSORBIDE DINITRATE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SORBITRATE","activeIngredients":"ISOSORBIDE DINITRATE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SORBITRATE","submission":"ISOSORBIDE DINITRATE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SORBITRATE","submission":"ISOSORBIDE DINITRATE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)