← FDA Drug Approvals (Drugs@FDA)
AZELASTINE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALEMBIC · Approved 2019-03-20
Drug application
- FDA Application #
ANDA209620- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- AZELASTINE HYDROCHLORIDE
- Generic name
- AZELASTINE HYDROCHLORIDE OPHTHALMIC SOLUTION 0.05%
- Active ingredients
- AZELASTINE HYDROCHLORIDE
- Dosage form
- SOLUTION/DROPS
- Route
- OPHTHALMIC
- Marketing status
- Prescription
- Sponsor
- ALEMBIC
- Manufacturer
- Alembic Pharmaceuticals Inc.
- First approval
- 2019-03-20
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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