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 LTD
 Intravesical Administration Kit 3000252026-03-23
UROGEN PHARMA LTD
 Urinary Catheter, 16 Fr UC00102025-11-25
UROGEN PHARMA LTD
 Urinary Catheter, 16 Fr UC00112025-11-25
UROGEN PHARMA LTD
 Urinary Catheter, 16 Fr UC00092025-11-24
UROGEN PHARMA LTD
 Urinary Catheter, 16 Fr UC00082025-11-24
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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