EUGIA PHARMA SPECLTS FDA Approval ANDA 213086

ANDA 213086

EUGIA PHARMA SPECLTS

FDA Drug Application

Application #213086

Application Sponsors

ANDA 213086EUGIA PHARMA SPECLTS

Marketing Status

None (Tentative Approval)001
None (Tentative Approval)002
None (Tentative Approval)003

Application Products

002CAPSULE;ORAL100MG0PALBOCICLIBPALBOCICLIB
003CAPSULE;ORAL125MG0PALBOCICLIBPALBOCICLIB

FDA Submissions

UNKNOWN; ORIG1TA2022-07-07STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

EUGIA PHARMA SPECLTS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213086
            [companyName] => EUGIA PHARMA SPECLTS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PALBOCICLIB","activeIngredients":"PALBOCICLIB","strength":"75MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PALBOCICLIB","activeIngredients":"PALBOCICLIB","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"PALBOCICLIB","activeIngredients":"PALBOCICLIB","strength":"125MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/07\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-07-07
        )

)

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