AMNEAL PHARMS NY FDA Approval ANDA 214292

ANDA 214292

AMNEAL PHARMS NY

FDA Drug Application

Application #214292

Documents

Letter2021-06-15

Application Sponsors

ANDA 214292AMNEAL PHARMS NY

Marketing Status

None (Tentative Approval)001

Application Products

001CAPSULE;ORAL0.02MG;1MG0NORETHIDRONE ACETATE;ETHINYL ESTRADIOL;FERROUS FUMARATENORETHIDRONE ACETATE;ETHINYL ESTRADIOL;FERROUS FUMARATE

FDA Submissions

UNKNOWN; ORIG1TA2021-05-12STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

AMNEAL PHARMS NY
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214292
            [companyName] => AMNEAL PHARMS NY
            [docInserts] => ["",""]
            [products] => [{"drugName":"NORETHIDRONE ACETATE;ETHINYL ESTRADIOL;FERROUS FUMARATE","activeIngredients":"NORETHIDRONE ACETATE;ETHINYL ESTRADIOL;FERROUS FUMARATE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"05\/12\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-05-12
        )

)

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