SPECGX LLC FDA Approval ANDA 213335

ANDA 213335

SPECGX LLC

FDA Drug Application

Application #213335

Application Sponsors

ANDA 213335SPECGX LLC

Marketing Status

Prescription001

Application Products

001TABLET;ORAL2.5MG;0.025MG0DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1AP2020-10-06STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAA

CDER Filings

SPECGX LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213335
            [companyName] => SPECGX LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE","activeIngredients":"ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE","strength":"2.5MG;0.025MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/06\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2020-10-06
        )

)

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