ANDA 083560

UPSHER SMITH LABS

FDA Drug Application

Application #083560

Application Sponsors

ANDA 083560

UPSHER SMITH LABS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET;ORAL

25MG

0

HYDRALAZINE HYDROCHLORIDE

HYDRALAZINE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1976-08-05
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	1985-08-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	1985-08-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	11	AP	1985-08-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	1985-08-15
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	1985-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	1985-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	1985-03-13
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	1985-05-06
MANUF (CMC); Manufacturing (CMC)	SUPPL	39	AP	1987-05-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	40	AP	1987-05-27
MANUF (CMC); Manufacturing (CMC)	SUPPL	42	AP	2000-01-28

Submissions Property Types

SUPPL	4	Null	0
SUPPL	10	Null	0
SUPPL	11	Null	0
SUPPL	12	Null	0
SUPPL	29	Null	0
SUPPL	31	Null	0
SUPPL	32	Null	0
SUPPL	37	Null	0
SUPPL	39	Null	0
SUPPL	40	Null	0
SUPPL	42	Null	0

CDER Filings

UPSHER SMITH LABS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 83560
            [companyName] => UPSHER SMITH LABS
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDRALAZINE HYDROCHLORIDE","activeIngredients":"HYDRALAZINE HYDROCHLORIDE","strength":"25MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"HYDRALAZINE HYDROCHLORIDE","submission":"HYDRALAZINE HYDROCHLORIDE","actionType":"25MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)