PADAGIS ISRAEL FDA Approval ANDA 212469

ANDA 212469

PADAGIS ISRAEL

FDA Drug Application

Application #212469

Documents

Letter2021-10-08

Application Sponsors

ANDA 212469PADAGIS ISRAEL

Marketing Status

Prescription001
Prescription002

Application Products

001SPRAY;NASAL2.5MG/SPRAY0ZOLMITRIPTANZOLMITRIPTAN
002SPRAY;NASAL5MG/SPRAY0ZOLMITRIPTANZOLMITRIPTAN

FDA Submissions

UNKNOWN; ORIG1AP2021-09-30STANDARD

Submissions Property Types

ORIG1Null15

TE Codes

001PrescriptionAB
002PrescriptionAB

CDER Filings

PADAGIS ISRAEL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 212469
            [companyName] => PADAGIS ISRAEL
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZOLMITRIPTAN","activeIngredients":"ZOLMITRIPTAN","strength":"2.5MG\/SPRAY","dosageForm":"SPRAY;NASAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"ZOLMITRIPTAN","activeIngredients":"ZOLMITRIPTAN","strength":"5MG\/SPRAY","dosageForm":"SPRAY;NASAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/30\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2021-09-30
        )

)

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