ANDA 071717

AUROLIFE PHARMA LLC

FDA Drug Application

Application #071717

Application Sponsors

ANDA 071717

AUROLIFE PHARMA LLC

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	CAPSULE;ORAL	30MG	0	FLURAZEPAM HYDROCHLORIDE	FLURAZEPAM HYDROCHLORIDE
002	CAPSULE;ORAL	15MG	0	FLURAZEPAM HYDROCHLORIDE	FLURAZEPAM HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	1991-07-31
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1994-01-24
LABELING; Labeling	SUPPL	4	AP	2016-12-16	STANDARD

Submissions Property Types

SUPPL	2	Null	0
SUPPL	4	Null	15

CDER Filings

AUROLIFE PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 71717
            [companyName] => AUROLIFE PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"FLURAZEPAM HYDROCHLORIDE","activeIngredients":"FLURAZEPAM HYDROCHLORIDE","strength":"30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"FLURAZEPAM HYDROCHLORIDE","activeIngredients":"FLURAZEPAM HYDROCHLORIDE","strength":"15MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"FLURAZEPAM HYDROCHLORIDE","submission":"FLURAZEPAM HYDROCHLORIDE","actionType":"30MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"FLURAZEPAM HYDROCHLORIDE","submission":"FLURAZEPAM HYDROCHLORIDE","actionType":"15MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)