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ZYLET

NDA · New Drug Application · Sponsor: BAUSCH AND LOMB · Approved 2004-12-14

Drug application

FDA Application #

NDA050804

Application type

New Drug Application

Brand name

ZYLET

Generic name

LOTEPREDNOL ETABONATE AND TOBRAMYCIN

Active ingredients

LOTEPREDNOL ETABONATE; TOBRAMYCIN

Dosage form

SUSPENSION/DROPS

Route

OPHTHALMIC

Marketing status

Prescription

Sponsor

BAUSCH AND LOMB

Manufacturer

Bausch & Lomb Americas Inc.

First approval

2004-12-14

Source

Authoritative

Drugs@FDA application overview

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