NDA 213872

BAYER HEALTHCARE LLC

FDA Drug Application

Application #213872

Documents

• Letter: 2021-06-21
• Label: 2021-06-21
• Letter: 2022-01-19
• Review: 2022-05-04

Application Sponsors

NDA 213872

BAYER HEALTHCARE LLC

Marketing Status

• Over-the-counter: 001
• Over-the-counter: 002

Application Products

001	SPRAY, METERED;NASAL	205.5MCG/SPRAY	2	ASTEPRO ALLERGY	AZELASTINE HYDROCHLORIDE
002	SPRAY, METERED;NASAL	205.5MCG/SPRAY	2	CHILDREN?S ASTEPRO ALLERGY	AZELASTINE HYDROCHLORIDE

FDA Submissions

TYPE 8; Type 8 - Partial Rx to OTC Switch

ORIG

1

AP

2021-06-17

STANDARD

Submissions Property Types

ORIG

1

Null

7

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
        )

)