ANDA 207084

AKORN INC

FDA Drug Application

Application #207084

Application Sponsors

ANDA 207084

AKORN INC

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

10MG/ML

0

DICYCLOMINE HYDROCHLORIDE

DICYCLOMINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-05-04

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

AKORN INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207084
            [companyName] => AKORN INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICYCLOMINE HYDROCHLORIDE","activeIngredients":"DICYCLOMINE HYDROCHLORIDE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/04\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-05-04
        )

)