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ORLYNVAH

NDA · New Drug Application · Sponsor: ITERUM THERAP · Approved 2024-10-25

Drug application

FDA Application #

NDA213972

Application type

New Drug Application

Brand name

ORLYNVAH

Generic name

SULOPENEM ETZADROXIL AND PROBENECID

Active ingredients

PROBENECID; SULOPENEM ETZADROXIL

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

ITERUM THERAP

Manufacturer

ITERUM THERAPEUTICS US LIMITED

First approval

2024-10-25

Source

Authoritative

Drugs@FDA application overview

Machine

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