ANDA 212058

SUNGEN PHARMA

FDA Drug Application

Application #212058

Application Sponsors

ANDA 212058

SUNGEN PHARMA

Marketing Status

• Prescription: 001

Application Products

001

INJECTABLE;INJECTION

10MG/ML

0

DICYCLOMINE HYDROCHLORIDE

DICYCLOMINE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2019-04-26

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AP

CDER Filings

SUNGEN PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212058
            [companyName] => SUNGEN PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"DICYCLOMINE HYDROCHLORIDE","activeIngredients":"DICYCLOMINE HYDROCHLORIDE","strength":"10MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/26\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2019-04-26
        )

)