ANDA 091591

HIKMA

FDA Drug Application

Application #091591

Application Sponsors

ANDA 091591

HIKMA

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE;ORAL

30MG

0

CEVIMELINE HYDROCHLORIDE

CEVIMELINE HYDROCHLORIDE

FDA Submissions

ORIG

1

AP

2013-07-08

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AB

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 91591
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CEVIMELINE HYDROCHLORIDE","activeIngredients":"CEVIMELINE HYDROCHLORIDE","strength":"30MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CEVIMELINE HYDROCHLORIDE","submission":"CEVIMELINE HYDROCHLORIDE","actionType":"30MG","submissionClassification":"CAPSULE;ORAL","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)