ANDA 083561

UPSHER SMITH LABS

FDA Drug Application

Application #083561

Application Sponsors

ANDA 083561

UPSHER SMITH LABS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

50MG

0

HYDRALAZINE HYDROCHLORIDE

HYDRALAZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1976-08-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	1985-08-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1985-08-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	1985-08-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1985-08-21
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1985-03-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	21	AP	1985-03-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	23	AP	1985-05-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	24	AP	1986-10-17
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	1986-08-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	27	AP	2000-01-28

Submissions Property Types

SUPPL	3	Null	0
SUPPL	8	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	20	Null	0
SUPPL	21	Null	0
SUPPL	23	Null	0
SUPPL	24	Null	0
SUPPL	25	Null	0
SUPPL	27	Null	0

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83561
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDRALAZINE HYDROCHLORIDE","activeIngredients":"HYDRALAZINE HYDROCHLORIDE","strength":"50MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDRALAZINE HYDROCHLORIDE","submission":"HYDRALAZINE HYDROCHLORIDE","actionType":"50MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)