← FDA Drug Approvals (Drugs@FDA)
AZELASTINE HYDROCHLORIDE ALLERGY
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA · Approved 2025-01-27
Drug application
- FDA Application #
ANDA216561- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- AZELASTINE HYDROCHLORIDE ALLERGY
- Generic name
- AZELASTINE HYDROCHLORIDE
- Active ingredients
- AZELASTINE HYDROCHLORIDE
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Marketing status
- Over-the-counter
- Sponsor
- AUROBINDO PHARMA
- Manufacturer
- Aurohealth LLC
- First approval
- 2025-01-27
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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