ANDA 077855

NESHER PHARMS

FDA Drug Application

Application #077855

Application Sponsors

ANDA 077855

NESHER PHARMS

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	100MG	0	MORPHINE SULFATE	MORPHINE SULFATE
002	TABLET, EXTENDED RELEASE;ORAL	200MG	0	MORPHINE SULFATE	MORPHINE SULFATE

FDA Submissions

	ORIG	1	AP	2007-09-27
LABELING; Labeling	SUPPL	3	AP	2008-01-10
LABELING; Labeling	SUPPL	7	AP	2015-04-22
LABELING; Labeling	SUPPL	8	AP	2015-05-08
REMS; REMS	SUPPL	13	AP	2015-06-26
REMS; REMS	SUPPL	16	AP	2016-04-20
REMS; REMS	SUPPL	17	AP	2016-09-30
REMS; REMS	SUPPL	18	AP	2017-05-26
LABELING; Labeling	SUPPL	19	AP	2019-12-10	STANDARD
REMS; REMS	SUPPL	20	AP	2018-09-18
LABELING; Labeling	SUPPL	21	AP	2019-12-10	STANDARD
LABELING; Labeling	SUPPL	22	AP	2019-12-10	STANDARD

Submissions Property Types

SUPPL	7	Null	7
SUPPL	8	Null	15
SUPPL	13	Null	15
SUPPL	16	Null	7
SUPPL	17	Null	7
SUPPL	18	Null	7
SUPPL	19	Null	15
SUPPL	20	Null	15
SUPPL	21	Null	7
SUPPL	22	Null	7

CDER Filings

NESHER PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 77855
            [companyName] => NESHER PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"100MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"200MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MORPHINE SULFATE","submission":"MORPHINE SULFATE","actionType":"100MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MORPHINE SULFATE","submission":"MORPHINE SULFATE","actionType":"200MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)