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JELMYTO

NDA · New Drug Application · Sponsor: UROGEN PHARMA · Approved 2020-04-15

Drug application

FDA Application #

NDA211728

Application type

New Drug Application

Brand name

JELMYTO

Generic name

MITOMYCIN

Active ingredients

MITOMYCIN

Dosage form

POWDER

Route

PYELOCALYCEAL

Marketing status

Prescription

Sponsor

UROGEN PHARMA

Manufacturer

UroGen Pharma, Inc.

First approval

2020-04-15

Source

Authoritative

Drugs@FDA application overview

Machine

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