ANDA 204762

HIKMA PHARMS

FDA Drug Application

Application #204762

Application Sponsors

ANDA 204762

HIKMA PHARMS

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

20MG/VIAL

0

DANTROLENE SODIUM

DANTROLENE SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-06-19

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

HIKMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204762
            [companyName] => HIKMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DANTROLENE SODIUM","activeIngredients":"DANTROLENE SODIUM","strength":"20MG\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/19\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-06-19
        )

)