UroGen Pharma
FDA Approved Drugs

UroGen Pharma

FDA Approved Drugs Database

FDA approved drug product records including application numbers, product numbers, drug names, active ingredients, dosage forms, strengths, approval dates and regulatory status.

RX
  • Total Records 2
  • Latest Approval Date Jun 12, 2025
  • Data Source FDA
  • First Approval Date Apr 15, 2020
Company Overview

Company

UroGen Pharma

Country

U.S.A

Social Profiles

LinkedIn X / Twitter
Company Snapshot

UroGen Pharma

499 Park Avenue, Suite 1200 New York, NY 10022

U.S.A

www.urogen.com/ info@urogen.com View on Map
FDA Approved Drug Records ( 2 records )
2020
15 Apr
RX Application: 211728

Drug Name

JELMYTO

Product Number

1

Dosage Form

-

Strength

40MG/VIAL

Approval Date

2020-04-15

211728 / 1

Active Ingredient

MITOMYCIN

Application Number

211728

Product Number

1

Dosage Form

-

Strength

40MG/VIAL

Approval Date

2020-04-15

Regulatory Status

RX

2025
12 Jun
RX Application: 215793

Drug Name

ZUSDURI

Product Number

1

Dosage Form

-

Strength

40MG/VIAL

Approval Date

2025-06-12

215793 / 1

Active Ingredient

MITOMYCIN

Application Number

215793

Product Number

1

Dosage Form

-

Strength

40MG/VIAL

Approval Date

2025-06-12

Regulatory Status

RX

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Drug Status Breakdown
2 total
  • RX
Official Source

FDA approved drug data is based on publicly available U.S. Food and Drug Administration Orange Book information.

Visit FDA Orange Book
FDA Approved Drug Record Details Preview

Explore important FDA approved drug information available in the records above.

Drug Name

JELMYTO

Application Number

211728

Product Number

1

Active Ingredient

MITOMYCIN

Dosage Form

-

Strength

40MG/VIAL

FDA Approved Drug Data

Approved drug product information

Regular Updates

Data maintained from official sources

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