ANDA 079217

AKORN INC

FDA Drug Application

Application #079217

Application Sponsors

ANDA 079217

AKORN INC

Marketing Status

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

Application Products

001	CAPSULE;ORAL	2.5MG	0	DRONABINOL	DRONABINOL
002	CAPSULE;ORAL	5MG	0	DRONABINOL	DRONABINOL
003	CAPSULE;ORAL	10MG	0	DRONABINOL	DRONABINOL

FDA Submissions

ORIG

1

AP

2014-06-20

Submissions Property Types

ORIG

1

Null

19

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

AKORN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 79217
            [companyName] => AKORN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DRONABINOL","activeIngredients":"DRONABINOL","strength":"2.5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DRONABINOL","activeIngredients":"DRONABINOL","strength":"5MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DRONABINOL","activeIngredients":"DRONABINOL","strength":"10MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"DRONABINOL","submission":"DRONABINOL","actionType":"2.5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DRONABINOL","submission":"DRONABINOL","actionType":"5MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"DRONABINOL","submission":"DRONABINOL","actionType":"10MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)