ANDA 201463

LANNETT CO INC

FDA Drug Application

Application #201463

Application Sponsors

ANDA 201463

LANNETT CO 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

N/A; Not Applicable	ORIG	1	AP	2018-05-18
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2021-06-14	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	6	Null	15

TE Codes

001	Prescription	AB
002	Prescription	AB
003	Prescription	AB

CDER Filings

LANNETT CO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 201463
            [companyName] => LANNETT CO 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":"05\/18\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-05-18
        )

)