Urogen Pharma L T D

FDA Filings

This page includes the latest FDA filings for Urogen Pharma L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

ISRAELNASDAQURGNDUNS 534155213

Urogen Pharma L T D holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3013024191
FEI Number3013024191
NameUROGEN PHARMA LTD.
Owner & OperatorUrogen Pharma Ltd.
Contact Address9 Ha'Ta'asiya Street P.O. Box 2397
Ra'anana IL-NOTA 4365007 IL
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address9 Ha'Ta'asiya Street
Ra'anana HaMerkaz, 4365007 IL
Establishment TypeDevelop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device
Company
DeviceDate
UroGen Pharma, Inc., UroGen Pharma, Ltd.
Prescription Medication2025-07-20
UroGen Pharma, Inc, UroGen Pharma, Ltd.
Prescription Medication2025-07-02
UROGEN PHARMA LTD
 Intravesical Administration Kit 3000062025-06-24
UroGen Pharma, Inc., UroGen Pharma, Ltd.
Prescription Medication2024-10-18
UroGen Pharma, Inc., UroGen Pharma, Ltd.
Prescription Medication2022-10-11
UROGEN PHARMA LTD
 Urinary Catheter UC00052022-06-09
UROGEN PHARMA LTD
 Urinary Catheter UC00062022-06-09
UROGEN PHARMA LTD
 Chilling Block UCB00022022-02-11
UroGen Pharma Ltd
Urinary Catheter 12 Fr, Urinary Catheter 16 Fr2021-11-19
UroGen Pharma, Inc., UroGen Pharma, Ltd.
Prescription Medication2021-01-29
UROGEN PHARMA LTD
 Cystoject Syringe Lever SL00042021-01-12
UroGen Pharma Ltd
Cystoject Syringe Lever2020-12-09
UROGEN PHARMA LTD
 Ureteral Catheter Administration Kit 2000062020-05-25
UROGEN PHARMA LTD
 Uroject12 Syringe Lever SL00022020-05-01
UroGen Pharma, Inc., UroGen Pharma, Ltd.
Prescription Medication2020-05-01
UROGEN PHARMA LTD
 Chilling Block 2020-04-22
UROGEN PHARMA LTD
 Chilling Block 2020-04-22
UROGEN PHARMA LTD
 7 Fr. Ureteral catheter 2020-04-22
UroGen Pharma Ltd.
Uroject12 Syringe Lever2019-12-02
UROGEN PHARMA LTD.
UroGen Ureteral Catheter2018-10-31
UROGEN PHARMA LTD.
Uroject12 Syringe Lever2018-10-31
UroGen Pharma Ltd.
UroGen Ureteral Catheter2018-10-30
UroGen Pharma Ltd.
Uroject12 Syringe Lever2018-10-17
UROGEN PHARMA LTD.
Chilling Block Urogen2017-10-24
UROGEN PHARMA LTD
0000-00-00 00:00:00

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