ANDA 203191

LANNETT CO INC

FDA Drug Application

Application #203191

Application Sponsors

ANDA 203191

LANNETT CO INC

Marketing Status

• Prescription: 001

Application Products

001

SYRUP;ORAL

2MG/5ML

0

CYPROHEPTADINE HYDROCHLORIDE

CYPROHEPTADINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-07-13

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AA

CDER Filings

LANNETT CO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203191
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"CYPROHEPTADINE HYDROCHLORIDE","activeIngredients":"CYPROHEPTADINE HYDROCHLORIDE","strength":"2MG\/5ML","dosageForm":"SYRUP;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/13\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-07-13
        )

)