ANDA 077290

NESHER PHARMS

FDA Drug Application

Application #077290

Application Sponsors

ANDA 077290

NESHER PHARMS

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003
• Discontinued: 004
• Discontinued: 005

Application Products

001	TABLET;ORAL	5MG	0	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE
002	TABLET;ORAL	10MG	0	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE
003	TABLET;ORAL	15MG	0	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE
004	TABLET;ORAL	20MG	0	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE
005	TABLET;ORAL	30MG	0	OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2005-12-08
LABELING; Labeling	SUPPL	6	AP	2009-04-29
LABELING; Labeling	SUPPL	7	AP	2015-04-27	STANDARD
REMS; REMS	SUPPL	24	AP	2018-09-18

Submissions Property Types

SUPPL	7	Null	15
SUPPL	24	Null	15

CDER Filings

NESHER PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77290
            [companyName] => NESHER PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"10MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"15MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"20MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"OXYCODONE HYDROCHLORIDE","activeIngredients":"OXYCODONE HYDROCHLORIDE","strength":"30MG","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"OXYCODONE HYDROCHLORIDE","submission":"OXYCODONE HYDROCHLORIDE","actionType":"5MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"OXYCODONE HYDROCHLORIDE","submission":"OXYCODONE HYDROCHLORIDE","actionType":"10MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"OXYCODONE HYDROCHLORIDE","submission":"OXYCODONE HYDROCHLORIDE","actionType":"15MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"OXYCODONE HYDROCHLORIDE","submission":"OXYCODONE HYDROCHLORIDE","actionType":"20MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"OXYCODONE HYDROCHLORIDE","submission":"OXYCODONE HYDROCHLORIDE","actionType":"30MG","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)