ANDA 203846

HIKMA

FDA Drug Application

Application #203846

Application Sponsors

ANDA 203846

HIKMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

5MG

0

METHAMPHETAMINE HYDROCHLORIDE

METHAMPHETAMINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2015-11-17

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AA

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203846
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"METHAMPHETAMINE HYDROCHLORIDE","activeIngredients":"METHAMPHETAMINE HYDROCHLORIDE","strength":"5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"11\/17\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2015-11-17
        )

)