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OFLOXACIN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SOMERSET THERAPS LLC · Approved 2024-10-15

Drug application

FDA Application #

ANDA216328

Application type

Abbreviated New Drug Application (Generic)

Brand name

OFLOXACIN

Generic name

OFLOXACIN

Active ingredients

OFLOXACIN

Dosage form

SOLUTION/DROPS

Route

OTIC

Marketing status

Prescription

Sponsor

SOMERSET THERAPS LLC

Manufacturer

Somerset Therapeutics, LLC

First approval

2024-10-15

Source

Authoritative

Drugs@FDA application overview

Machine

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