PERRIGO PHARMA INTL FDA Approval NDA 215712

NDA 215712

PERRIGO PHARMA INTL

FDA Drug Application

Application #215712

Documents

Label2022-03-18
Letter2022-03-18

Application Sponsors

NDA 215712PERRIGO PHARMA INTL

Marketing Status

Over-the-counter001

Application Products

001SPRAY, METERED;NASAL0.05MG/SPRAY1NASONEX 24HR ALLERGYMOMETASONE FUROATE

FDA Submissions

TYPE 8; Type 8 - Partial Rx to OTC SwitchORIG1AP2022-03-17STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

PERRIGO PHARMA INTL
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 215712
            [companyName] => PERRIGO PHARMA INTL
            [docInserts] => ["",""]
            [products] => [{"drugName":"NASONEX 24HR ALLERGY","activeIngredients":"MOMETASONE FUROATE","strength":"50MCG","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Over-the-counter","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"03\/17\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215712Orig1s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"03\/17\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 8 - Partial Rx to OTC Switch","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/215712Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/215712Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-03-17
        )

)

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