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 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 |
Formulation / Manufacturing: | see details |
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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