← FDA Drug Approvals (Drugs@FDA)

EPINASTINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SOMERSET THERAPS LLC · Approved 2011-10-31

Drug application

FDA Application #

ANDA090951

Application type

Abbreviated New Drug Application (Generic)

Brand name

EPINASTINE HYDROCHLORIDE

Generic name

EPINASTINE HYDROCHLORIDE

Active ingredients

EPINASTINE HYDROCHLORIDE

Dosage form

SOLUTION/DROPS

Route

OPHTHALMIC

Marketing status

Prescription

Sponsor

SOMERSET THERAPS LLC

Manufacturer

Somerset Therapeutics, LLC

First approval

2011-10-31

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown