EUGIA PHARMA SPECLTS FDA Approval ANDA 216379

ANDA 216379

EUGIA PHARMA SPECLTS

FDA Drug Application

Application #216379

Application Sponsors

ANDA 216379EUGIA PHARMA SPECLTS

Marketing Status

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

Application Products

002SOLUTION;INTRAVENOUSEQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)0TIROFIBAN HYDROCHLORIDETIROFIBAN HYDROCHLORIDE

FDA Submissions

UNKNOWN; ORIG1TA2022-04-21STANDARD

Submissions Property Types

ORIG1Null31

CDER Filings

EUGIA PHARMA SPECLTS
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216379
            [companyName] => EUGIA PHARMA SPECLTS
            [docInserts] => ["",""]
            [products] => [{"drugName":"TIROFIBAN HYDROCHLORIDE","activeIngredients":"TIROFIBAN HYDROCHLORIDE","strength":"EQ 5MG BASE\/100ML (EQ 0.05MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"TIROFIBAN HYDROCHLORIDE","activeIngredients":"TIROFIBAN HYDROCHLORIDE","strength":"EQ 12.5MG BASE\/250ML (EQ 0.05MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"04\/21\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-04-21
        )

)

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