ANDA 076720

NESHER PHARMS

FDA Drug Application

Application #076720

Documents

• Other: 2015-06-30

Application Sponsors

ANDA 076720

NESHER PHARMS

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	60MG	0	MORPHINE SULFATE	MORPHINE SULFATE
002	TABLET, EXTENDED RELEASE;ORAL	30MG	0	MORPHINE SULFATE	MORPHINE SULFATE

FDA Submissions

	ORIG	1	AP	2004-05-19
LABELING; Labeling	SUPPL	2	AP	2005-12-23
LABELING; Labeling	SUPPL	7	AP	2008-01-10
LABELING; Labeling	SUPPL	12	AP	2015-04-22
LABELING; Labeling	SUPPL	13	AP	2015-05-08
REMS; REMS	SUPPL	17	AP	2015-06-26
REMS; REMS	SUPPL	19	AP	2016-04-20
REMS; REMS	SUPPL	20	AP	2016-09-30
REMS; REMS	SUPPL	21	AP	2017-05-26
LABELING; Labeling	SUPPL	22	AP	2019-12-10	STANDARD
REMS; REMS	SUPPL	23	AP	2018-09-18
LABELING; Labeling	SUPPL	24	AP	2019-12-10	STANDARD
LABELING; Labeling	SUPPL	25	AP	2019-12-10	STANDARD

Submissions Property Types

SUPPL	12	Null	7
SUPPL	13	Null	19
SUPPL	17	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
SUPPL	25	Null	7

TE Codes

001	Prescription	AB
002	Prescription	AB

CDER Filings

NESHER PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 76720
            [companyName] => NESHER PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"60MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"30MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"MORPHINE SULFATE","submission":"MORPHINE SULFATE","actionType":"60MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"MORPHINE SULFATE","submission":"MORPHINE SULFATE","actionType":"30MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)