ANDA 213906

SUN PHARM INDS INC

FDA Drug Application

Application #213906

Application Sponsors

ANDA 213906

SUN PHARM INDS INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

2MG

0

LEVORPHANOL TARTRATE

LEVORPHANOL TARTRATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2021-06-17

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AB

CDER Filings

SUN PHARM INDS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213906
            [companyName] => SUN PHARM INDS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"LEVORPHANOL TARTRATE","activeIngredients":"LEVORPHANOL TARTRATE","strength":"2MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"06\/17\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-06-17
        )

)