Details for New Drug Application (NDA): 216421
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NDA 216421 describes AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY, which is a drug marketed by Apotex and is included in one NDA. It is available from one supplier. Additional details are available on the AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY profile page.
The generic ingredient in AZELASTINE HYDROCHLORIDE CHILDREN'S 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 AZELASTINE HYDROCHLORIDE CHILDREN'S 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 216421
| Tradename: | AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY |
| Applicant: | Apotex |
| Ingredient: | azelastine hydrochloride |
| Patents: | 0 |
Pharmacology for NDA: 216421
| Mechanism of Action | Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 216421
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| AZELASTINE HYDROCHLORIDE ALLERGY | azelastine hydrochloride | SPRAY, METERED;NASAL | 216421 | ANDA | Walgreens | 0363-0653 | 0363-0653-03 | 1 BOTTLE, SPRAY in 1 CARTON (0363-0653-03) / 60 SPRAY, METERED in 1 BOTTLE, SPRAY (0363-0653-01) |
| AZELASTINE HYDROCHLORIDE ALLERGY | azelastine hydrochloride | SPRAY, METERED;NASAL | 216421 | ANDA | Walgreens | 0363-0653 | 0363-0653-04 | 1 BOTTLE, SPRAY in 1 CARTON (0363-0653-04) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY (0363-0653-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SPRAY, METERED;NASAL | Strength | 0.2055MG/SPRAY | ||||
| Approval Date: | May 29, 2024 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | OTC | Dosage: | SPRAY, METERED;NASAL | Strength | 0.2055MG/SPRAY | ||||
| Approval Date: | May 29, 2024 | TE: | RLD: | No | |||||
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