ANDA 091357

EPIC PHARMA LLC

FDA Drug Application

Application #091357

Documents

• Other: 2016-06-28

Application Sponsors

ANDA 091357

EPIC PHARMA LLC

Marketing Status

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

Application Products

001	TABLET, EXTENDED RELEASE;ORAL	15MG	0	MORPHINE SULFATE	MORPHINE SULFATE
002	TABLET, EXTENDED RELEASE;ORAL	30MG	0	MORPHINE SULFATE	MORPHINE SULFATE
003	TABLET, EXTENDED RELEASE;ORAL	60MG	0	MORPHINE SULFATE	MORPHINE SULFATE
004	TABLET, EXTENDED RELEASE;ORAL	100MG	0	MORPHINE SULFATE	MORPHINE SULFATE
005	TABLET, EXTENDED RELEASE;ORAL	200MG	0	MORPHINE SULFATE	MORPHINE SULFATE

FDA Submissions

	ORIG	1	AP	2016-06-23
REMS; REMS	SUPPL	3	AP	2017-05-26
REMS; REMS	SUPPL	4	AP	2018-09-18

Submissions Property Types

ORIG	1	Null	7
SUPPL	3	Null	7
SUPPL	4	Null	7

CDER Filings

EPIC PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91357
            [companyName] => EPIC PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"15MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"30MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"60MG","dosageForm":"TABLET, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"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":"15MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MORPHINE SULFATE","submission":"MORPHINE SULFATE","actionType":"30MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"MORPHINE SULFATE","submission":"MORPHINE SULFATE","actionType":"60MG","submissionClassification":"TABLET, EXTENDED RELEASE;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"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
        )

)