ANDA 205758

HIKMA

FDA Drug Application

Application #205758

Documents

• Letter: 2015-05-27

Application Sponsors

ANDA 205758

HIKMA

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	INJECTABLE;INJECTION	4MG/ML	0	MORPHINE SULFATE	MORPHINE SULFATE
002	INJECTABLE;INJECTION	8MG/ML	0	MORPHINE SULFATE	MORPHINE SULFATE
003	INJECTABLE;INJECTION	10MG/ML	0	MORPHINE SULFATE	MORPHINE SULFATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2015-05-21

STANDARD

Submissions Property Types

ORIG

1

Null

1

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205758
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"4MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"8MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"MORPHINE SULFATE","activeIngredients":"MORPHINE SULFATE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/21\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/205758Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-05-21
        )

)