← FDA Drug Approvals (Drugs@FDA)

OFLOXACIN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL · Approved 2019-08-30

Drug application

FDA Application #

ANDA211525

Application type

Abbreviated New Drug Application (Generic)

Brand name

OFLOXACIN

Generic name

OFLOXACIN OTIC

Active ingredients

OFLOXACIN

Dosage form

SOLUTION/DROPS

Route

OTIC

Marketing status

Prescription

Sponsor

AMNEAL

Manufacturer

Amneal Pharmaceuticals NY LLC

First approval

2019-08-30

Source

Authoritative

Drugs@FDA application overview

Machine

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