AMNEAL PHARMS LLC FDA Approval ANDA 215398

ANDA 215398

AMNEAL PHARMS LLC

FDA Drug Application

Application #215398

Application Sponsors

ANDA 215398AMNEAL PHARMS LLC

Marketing Status

Prescription001

Application Products

001GEL;TOPICAL1%0BEXAROTENEBEXAROTENE

FDA Submissions

UNKNOWN; ORIG1AP2022-04-27UNKNOWN

Submissions Property Types

ORIG1Null7

TE Codes

001PrescriptionAB

CDER Filings

AMNEAL PHARMS LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215398
            [companyName] => AMNEAL PHARMS LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"BEXAROTENE","activeIngredients":"BEXAROTENE","strength":"1%","dosageForm":"GEL;TOPICAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/27\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-04-27
        )

)

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