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AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: APOTEX · Approved 2024-05-29
Drug application
- FDA Application #
ANDA216421- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGY
- Generic name
- AZELASTINE HYDROCHLORIDE
- Active ingredients
- AZELASTINE HYDROCHLORIDE
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Marketing status
- Over-the-counter
- Sponsor
- APOTEX
- Manufacturer
- Allegiant Health
- First approval
- 2024-05-29
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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