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.
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 |
| 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: | ⤷ Try a Trial | Patent Expiration: | Jun 4, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Try a Trial | 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: | ⤷ Try a Trial | Patent Expiration: | Nov 22, 2025 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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