ANDA 086031

WATSON LABS TEVA

FDA Drug Application

Application #086031

Application Sponsors

ANDA 086031

WATSON LABS TEVA

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;SUBLINGUAL

5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**

0

ISOSORBIDE DINITRATE

ISOSORBIDE DINITRATE

FDA Submissions

	ORIG	1	AP	1987-09-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	16	AP	1985-02-25
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1985-06-17
LABELING; Labeling	SUPPL	20	AP	1988-06-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1990-06-29
MANUF (CMC); Manufacturing (CMC)	SUPPL	22	AP	1991-02-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1991-02-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1991-08-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	26	AP	1990-11-19
LABELING; Labeling	SUPPL	27	AP	1991-09-12
LABELING; Labeling	SUPPL	28	AP	1992-04-02
LABELING; Labeling	SUPPL	29	AP	1992-08-25
LABELING; Labeling	SUPPL	30	AP	1996-12-10

Submissions Property Types

SUPPL	16	Null	0
SUPPL	17	Null	0
SUPPL	21	Null	0
SUPPL	22	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	26	Null	0

CDER Filings

WATSON LABS TEVA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 86031
            [companyName] => WATSON LABS TEVA
            [docInserts] => ["",""]
            [products] => [{"drugName":"ISOSORBIDE DINITRATE","activeIngredients":"ISOSORBIDE DINITRATE","strength":"5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","dosageForm":"TABLET;SUBLINGUAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"ISOSORBIDE DINITRATE","submission":"ISOSORBIDE DINITRATE","actionType":"5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**","submissionClassification":"TABLET;SUBLINGUAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)