ANDA 076733

NESHER PHARMS

FDA Drug Application

Application #076733

Documents

• Other: 2015-06-30

Application Sponsors

ANDA 076733

NESHER PHARMS

Marketing Status

• Discontinued: 001

Application Products

001

TABLET, EXTENDED RELEASE;ORAL

15MG

0

MORPHINE SULFATE

MORPHINE SULFATE

FDA Submissions

	ORIG	1	AP	2004-05-19
LABELING; Labeling	SUPPL	7	AP	2008-01-10
LABELING; Labeling	SUPPL	11	AP	2015-04-22
LABELING; Labeling	SUPPL	12	AP	2015-05-08
REMS; REMS	SUPPL	16	AP	2015-06-26
REMS; REMS	SUPPL	18	AP	2016-04-20
REMS; REMS	SUPPL	19	AP	2016-09-30
REMS; REMS	SUPPL	20	AP	2017-05-26
LABELING; Labeling	SUPPL	21	AP	2019-12-10	STANDARD
REMS; REMS	SUPPL	22	AP	2018-09-18
LABELING; Labeling	SUPPL	23	AP	2019-12-10	STANDARD
LABELING; Labeling	SUPPL	24	AP	2019-12-10	STANDARD

Submissions Property Types

SUPPL	11	Null	15
SUPPL	12	Null	19
SUPPL	16	Null	7
SUPPL	18	Null	7
SUPPL	19	Null	7
SUPPL	20	Null	15
SUPPL	21	Null	15
SUPPL	22	Null	15
SUPPL	23	Null	7
SUPPL	24	Null	7

CDER Filings

NESHER PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76733
            [companyName] => NESHER PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"15MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MORPHINE SULFATE","submission":"MORPHINE SULFATE","actionType":"15MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)