ANDA 210819

BAYSHORE PHARMS LLC

FDA Drug Application

Application #210819

Application Sponsors

ANDA 210819

BAYSHORE PHARMS 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

2018-11-13

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001

Prescription

AA

CDER Filings

BAYSHORE PHARMS LLC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 210819
            [companyName] => BAYSHORE PHARMS 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":"11\/13\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2018-11-13
        )

)