ANDA 201947

VISTAPHARM

FDA Drug Application

Application #201947

Application Sponsors

ANDA 201947

VISTAPHARM

Marketing Status

• Discontinued: 001
• Discontinued: 002

Application Products

001	SOLUTION;ORAL	10MG/5ML	0	MORPHINE SULFATE	MORPHINE SULFATE
002	SOLUTION;ORAL	20MG/5ML	0	MORPHINE SULFATE	MORPHINE SULFATE

FDA Submissions

N/A; Not Applicable	ORIG	1	AP	2012-01-05
REMS; REMS	SUPPL	4	AP	2018-09-18

Submissions Property Types

ORIG	1	Null	42
SUPPL	4	Null	15

CDER Filings

VISTAPHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201947
            [companyName] => VISTAPHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"10MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"20MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"01\/05\/2012","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"09\/18\/2018","submission":"SUPPL-4","supplementCategories":"REMS - PROPOSAL - D-N-A","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2018-09-18
        )

)