ANDA 207108

LANNETT CO INC

FDA Drug Application

Application #207108

Application Sponsors

ANDA 207108

LANNETT CO INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;ORAL

5MG/5ML

0

HYDROMORPHONE HYDROCHLORIDE

HYDROMORPHONE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-04-22

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AA

CDER Filings

LANNETT CO INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207108
            [companyName] => LANNETT CO INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"HYDROMORPHONE HYDROCHLORIDE","activeIngredients":"HYDROMORPHONE HYDROCHLORIDE","strength":"5MG\/5ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/22\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-04-22
        )

)