NDA 016776

ASTRAZENECA

FDA Drug Application

Application #016776

Application Sponsors

NDA 016776

ASTRAZENECA

Marketing Status

• Discontinued: 002
• Discontinued: 003

Application Products

002	TABLET, CHEWABLE;ORAL	5MG	0	SORBITRATE	ISOSORBIDE DINITRATE
003	TABLET, CHEWABLE;ORAL	10MG	0	SORBITRATE	ISOSORBIDE DINITRATE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	1970-12-07	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	15	AP	1977-11-28	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1982-01-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	34	AP	1996-04-01	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	35	AP	1996-10-11	STANDARD
LABELING; Labeling	SUPPL	36	AP	1999-01-26	STANDARD

Submissions Property Types

ORIG	1	Null	0
SUPPL	15	Null	0
SUPPL	23	Null	0
SUPPL	34	Null	0
SUPPL	35	Null	0
SUPPL	36	Null	0

CDER Filings

ASTRAZENECA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 16776
            [companyName] => ASTRAZENECA
            [docInserts] => ["",""]
            [products] => [{"drugName":"SORBITRATE","activeIngredients":"ISOSORBIDE DINITRATE","strength":"5MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"SORBITRATE","activeIngredients":"ISOSORBIDE DINITRATE","strength":"10MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"SORBITRATE","submission":"ISOSORBIDE DINITRATE","actionType":"5MG","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"SORBITRATE","submission":"ISOSORBIDE DINITRATE","actionType":"10MG","submissionClassification":"TABLET, CHEWABLE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)