← FDA Drug Approvals (Drugs@FDA)
AZELASTINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: EPIC PHARMA LLC · Approved 2019-05-17
Drug application
- FDA Application #
ANDA207610
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- AZELASTINE HYDROCHLORIDE
- Generic name
- Azelastine Hydrochloride
- Active ingredients
- AZELASTINE HYDROCHLORIDE
- Dosage form
- SPRAY, METERED
- Route
- NASAL
- Marketing status
- Prescription
- Sponsor
- EPIC PHARMA LLC
- First approval
- 2019-05-17
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown