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LOTEPREDNOL ETABONATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL · Approved 2024-12-13

Drug application

FDA Application #

ANDA216345

Application type

Abbreviated New Drug Application (Generic)

Brand name

LOTEPREDNOL ETABONATE

Generic name

LOTEPREDNOL ETABONATE

Active ingredients

LOTEPREDNOL ETABONATE

Dosage form

SUSPENSION/DROPS

Route

OPHTHALMIC

Marketing status

Prescription

Sponsor

AMNEAL

Manufacturer

Amneal Pharmaceuticals NY LLC

First approval

2024-12-13

Source

Authoritative

Drugs@FDA application overview

Machine

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