BAYER HEALTHCARE LLC FDA Approval NDA 213872

NDA 213872

BAYER HEALTHCARE LLC

FDA Drug Application

Application #213872

Documents

Letter2021-06-21
Label2021-06-21

Application Sponsors

NDA 213872BAYER HEALTHCARE LLC

Marketing Status

Over-the-counter001
Over-the-counter002

Application Products

001SPRAY, METERED;NASAL205.5MCG/SPRAY2ASTEPRO ALLERGYAZELASTINE HYDROCHLORIDE
002SPRAY, METERED;NASAL205.5MCG/SPRAY2CHILDREN?S ASTEPRO ALLERGYAZELASTINE HYDROCHLORIDE

FDA Submissions

TYPE 8; Type 8 - Partial Rx to OTC SwitchORIG1AP2021-06-17STANDARD

Submissions Property Types

ORIG1Null7

CDER Filings

BAYER HEALTHCARE LLC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213872
            [companyName] => BAYER HEALTHCARE LLC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ASTEPRO ALLERGY","activeIngredients":"AZELASTINE HYDROCHLORIDE","strength":"205.5MCG\/SPRAY","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Over-the-counter","te":"None","rld":"TBD","rs":"No"},{"drugName":"CHILDREN\u2019S ASTEPRO ALLERGY","activeIngredients":"AZELASTINE HYDROCHLORIDE","strength":"205.5MCG\/SPRAY","dosageForm":"SPRAY, METERED;NASAL","marketingStatus":"Over-the-counter","te":"None","rld":"TBD","rs":"No"}]
            [labels] => [{"actionDate":"06\/17\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/213872Orig1s000Lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/17\/2021","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\\\/2021\\\/213872Orig1s000Lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/213872Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-06-17
        )

)

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