← FDA Drug Approvals (Drugs@FDA)
BEPOTASTINE BESILATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALEMBIC · Approved 2023-04-05
Drug application
- FDA Application #
ANDA214588- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- BEPOTASTINE BESILATE
- Generic name
- BEPOTASTINE BESILATE OPHTHALMIC SOLUTION 1.5%
- Active ingredients
- BEPOTASTINE BESILATE
- Dosage form
- SOLUTION/DROPS
- Route
- OPHTHALMIC
- Marketing status
- Prescription
- Sponsor
- ALEMBIC
- Manufacturer
- Alembic Pharmaceuticals Limited
- First approval
- 2023-04-05
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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