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.

ISRAEL

NASDAQ

URGN

DUNS 534155213

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

UROGEN PHARMA LTD.

FDA Registration(s)

Registration Number	3013024191
FEI Number	3013024191
Name	UROGEN PHARMA LTD.
Owner & Operator	Urogen Pharma Ltd.
Contact Address	9 Ha'Ta'asiya Street P.O. Box 2397 Ra'anana IL-NOTA 4365007 IL
US Agent	James G. Ottinger, R. Ph. Urogen Pharma Ltd. 610 7451230 646 9181262 jim.ottinger@urogen.com
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	9 Ha'Ta'asiya Street Ra'anana HaMerkaz, 4365007 IL
Establishment Type	Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
JELMYTO UroGen Pharma, Inc., UroGen Pharma, Ltd.	Prescription Medication	2022-10-11
GUDID 20854913006116 UROGEN PHARMA LTD	Urinary Catheter UC0005	2022-06-09
GUDID 10854913006126 UROGEN PHARMA LTD	Urinary Catheter UC0006	2022-06-09
GUDID 10854913006140 UROGEN PHARMA LTD	Chilling Block UCB0002	2022-02-11
PMN K211032 UroGen Pharma Ltd	Urinary Catheter 12 Fr, Urinary Catheter 16 Fr	2021-11-19
JELMYTO UroGen Pharma, Inc., UroGen Pharma, Ltd.	Prescription Medication	2021-01-29
GUDID 20854913006048 UROGEN PHARMA LTD	Cystoject Syringe Lever SL0004	2021-01-12
PMN K203321 UroGen Pharma Ltd	Cystoject Syringe Lever	2020-12-09
GUDID 10854913006096 UROGEN PHARMA LTD	Ureteral Catheter Administration Kit 200006	2020-05-25
GUDID 00854913006037 UROGEN PHARMA LTD	Uroject12 Syringe Lever SL0002	2020-05-01
JELMYTO UroGen Pharma, Inc., UroGen Pharma, Ltd.	Prescription Medication	2020-05-01
GUDID 10854913006089 UROGEN PHARMA LTD	Chilling Block	2020-04-22
GUDID 10854913006072 UROGEN PHARMA LTD	Chilling Block	2020-04-22
GUDID 10854913006058 UROGEN PHARMA LTD	7 Fr. Ureteral catheter	2020-04-22
PMN K190987 UroGen Pharma Ltd.	Uroject12 Syringe Lever	2019-12-02
PMN K180354 \| KOD UROGEN PHARMA LTD.	UroGen Ureteral Catheter	2018-10-31
PMN K180345 \| FMF UROGEN PHARMA LTD.	Uroject12 Syringe Lever	2018-10-31
PMN K180354 UroGen Pharma Ltd.	UroGen Ureteral Catheter	2018-10-30
PMN K180345 UroGen Pharma Ltd.	Uroject12 Syringe Lever	2018-10-17
LXG UROGEN PHARMA LTD.	Chilling Block Urogen	2017-10-24
211728 NDA UROGEN PHARMA LTD		0000-00-00 00:00:00