ECI PHARMS LLC FDA Approval ANDA 207128

ANDA 207128

ECI PHARMS LLC

FDA Drug Application

Application #207128

Application Sponsors

ANDA 207128ECI PHARMS LLC

Marketing Status

Prescription001

Application Products

001TABLET;ORAL0.025MG;2.5MG0DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-10-21STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAA

CDER Filings

ECI PHARMS LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207128
            [companyName] => ECI 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":"10\/21\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-21
        )

)

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.