ANDA 085088

UPSHER SMITH LABS

FDA Drug Application

Application #085088

Application Sponsors

ANDA 085088

UPSHER SMITH LABS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

50MG

0

HYDRALAZINE HYDROCHLORIDE

HYDRALAZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1994-09-16
MANUF (CMC); Manufacturing (CMC)	SUPPL	8	AP	1983-04-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1983-04-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1983-04-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	14	AP	1983-04-07
MANUF (CMC); Manufacturing (CMC)	SUPPL	17	AP	1983-02-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	18	AP	1983-02-22
MANUF (CMC); Manufacturing (CMC)	SUPPL	19	AP	1983-11-03
MANUF (CMC); Manufacturing (CMC)	SUPPL	20	AP	1983-11-03

Submissions Property Types

SUPPL	8	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	0
SUPPL	17	Null	0
SUPPL	18	Null	0
SUPPL	19	Null	0
SUPPL	20	Null	0

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 85088
            [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
        )

)