ANDA 206477

LANNETT CO INC

FDA Drug Application

Application #206477

Application Sponsors

ANDA 206477

LANNETT CO INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

5MG/5ML

0

DIAZEPAM

DIAZEPAM

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-06-24	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-02-05	STANDARD

Submissions Property Types

ORIG	1	Null	1
SUPPL	2	Null	15

TE Codes

001

Prescription

AA

CDER Filings

LANNETT CO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206477
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIAZEPAM","activeIngredients":"DIAZEPAM","strength":"5MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/24\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2016-06-24
        )

)