← FDA Drug Approvals (Drugs@FDA)
AZELASTINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL · Approved 2024-06-05
Drug application
- FDA Application #
ANDA216576- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- AZELASTINE HYDROCHLORIDE
- Generic name
- AZELASTINE
- Active ingredients
- AZELASTINE HYDROCHLORIDE
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Marketing status
- Discontinued
- Sponsor
- AMNEAL
- Manufacturer
- Amneal Pharmaceuticals NY LLC
- First approval
- 2024-06-05
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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