Details for New Drug Application (NDA): 213872
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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
Mechanism of Action | Histamine H1 Receptor Antagonists |
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: | OTC | Dosage: | SPRAY, METERED;NASAL | Strength | 0.2055MG/SPRAY | ||||
Approval Date: | Jun 17, 2021 | TE: | RLD: | Yes | |||||
Patent: | ⤷ Sign Up | Patent Expiration: | Jun 4, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Patent: | ⤷ Sign Up | Patent Expiration: | Nov 22, 2025 | Product 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 Up | Patent Expiration: | Nov 22, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? |
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