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 is one patent 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-two 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-two 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: | 1 |
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: | 8,071,073 | Patent Expiration: | Jun 4, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SPRAY, METERED;NASAL | Strength | 0.2055MG/SPRAY | ||||
| Approval Date: | Jun 17, 2021 | TE: | RLD: | Yes | |||||
| Patent: | 8,071,073 | Patent Expiration: | Jun 4, 2028 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
Expired US Patents for NDA 213872
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bayer Hlthcare | ASTEPRO ALLERGY | azelastine hydrochloride | SPRAY, METERED;NASAL | 213872-001 | Jun 17, 2021 | 8,518,919 | ⤷ Get Started Free |
| Bayer Hlthcare | CHILDREN'S ASTEPRO ALLERGY | azelastine hydrochloride | SPRAY, METERED;NASAL | 213872-002 | Jun 17, 2021 | 9,919,050 | ⤷ Get Started Free |
| Bayer Hlthcare | ASTEPRO ALLERGY | azelastine hydrochloride | SPRAY, METERED;NASAL | 213872-001 | Jun 17, 2021 | 9,919,050 | ⤷ Get Started Free |
| Bayer Hlthcare | CHILDREN'S ASTEPRO ALLERGY | azelastine hydrochloride | SPRAY, METERED;NASAL | 213872-002 | Jun 17, 2021 | 8,518,919 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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