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Last Updated: November 2, 2024

Details for New Drug Application (NDA): 213872


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NDA 213872 describes CHILDREN'S ASTEPRO ALLERGY, which is a drug marketed by Bayer Hlthcare and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the CHILDREN'S ASTEPRO ALLERGY profile page.

The generic ingredient in CHILDREN'S ASTEPRO ALLERGY is azelastine hydrochloride. There are twelve drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride profile page.
Summary for 213872
Tradename:CHILDREN'S ASTEPRO ALLERGY
Applicant:Bayer Hlthcare
Ingredient:azelastine hydrochloride
Patents:3
Pharmacology for NDA: 213872
Suppliers and Packaging for NDA: 213872
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ASTEPRO ALLERGY azelastine hydrochloride SPRAY, METERED;NASAL 213872 NDA Bayer HealthCare LLC. 0280-0065 0280-0065-01 60 CARTON in 1 BOTTLE (0280-0065-01) / 1 SPRAY, METERED in 1 CARTON
ASTEPRO ALLERGY azelastine hydrochloride SPRAY, METERED;NASAL 213872 NDA Bayer HealthCare LLC. 0280-0065 0280-0065-02 120 CARTON in 1 BOTTLE (0280-0065-02) / 1 SPRAY, METERED in 1 CARTON

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:SPRAY, METERED;NASALStrength0.2055MG/SPRAY
Approval Date:Jun 17, 2021TE:RLD:Yes
Patent:⤷  Sign UpPatent Expiration:Jun 4, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:⤷  Sign UpPatent Expiration:Nov 22, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:OTC USE: ALLERGY SYMPTOM RELIEVER; TEMPORARY RELIEF OF THESE SYMPTOMS DUE TO HAY FEVER OR OTHER UPPER RESPIRATORY ALLERGIES: NASAL CONGESTION, RUNNY NOSE, SNEEZING AND ITCHY NOSE
Patent:⤷  Sign UpPatent Expiration:Nov 22, 2025Product Flag?YSubstance Flag?Delist Request?

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