ANDA 213413

LEADING PHARMA LLC

FDA Drug Application

Application #213413

Application Sponsors

ANDA 213413

LEADING PHARMA LLC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

0.025MG;2.5MG

0

DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE

ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2020-02-20

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001

Prescription

AA

CDER Filings

LEADING PHARMA LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213413
            [companyName] => LEADING PHARMA LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE","activeIngredients":"ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE","strength":"0.025MG;2.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"02\/20\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-02-20
        )

)