Home Applications 211728 Application 211728
Type NDA
Sponsor UROGEN PHARMA LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 JELMYTO MITOMYCIN SOLUTION;PYELOCALYCEAL Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N211728-001 JELMYTO MITOMYCIN 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15
Orange Book patents# Current patent rows page 1 of 1 · 3 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N211728-001 12268745 2031-01-20 U-4172 2025-04-28 N211728-001 9040074 2031-01-20 Drug product 2020-04-29 N211728-001 9950069 2031-01-20 Drug product 2020-04-29
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N211728-001 ODE-289 2027-04-15
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N211728-001 JELMYTO 40MG/VIAL POWDER / PYELOCALYCEAL RLD, RS 2020-04-15 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 84 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N211728-001 12268745 2031-01-20 U-4172 2025-04-28 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211728-001 9040074 2031-01-20 Drug product 2020-04-29 84e616aacf4f…2026-09-14 22:38:34 2026-08 N211728-001 9950069 2031-01-20 Drug product 2020-04-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 N211728-001 12268745 2031-01-20 U-4172 2025-04-28 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211728-001 9040074 2031-01-20 Drug product 2020-04-29 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N211728-001 9950069 2031-01-20 Drug product 2020-04-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N211728-001 12268745 2031-01-20 U-4172 2025-04-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211728-001 9040074 2031-01-20 Drug product 2020-04-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211728-001 9950069 2031-01-20 Drug product 2020-04-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211728-001 12268745 2031-01-20 U-4172 2025-04-28 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211728-001 9040074 2031-01-20 Drug product 2020-04-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211728-001 9950069 2031-01-20 Drug product 2020-04-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211728-001 12268745 2031-01-20 U-4172 2025-04-28 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211728-001 9040074 2031-01-20 Drug product 2020-04-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N211728-001 9950069 2031-01-20 Drug product 2020-04-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211728-001 9040074 2031-01-20 Drug product 2020-04-29 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211728-001 9950069 2031-01-20 Drug product 2020-04-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211728-001 9040074 2031-01-20 Drug product 2020-04-29 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211728-001 9950069 2031-01-20 Drug product 2020-04-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211728-001 9040074 2031-01-20 Drug product 2020-04-29 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211728-001 9950069 2031-01-20 Drug product 2020-04-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211728-001 9040074 2031-01-20 Drug product 2020-04-29 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211728-001 9950069 2031-01-20 Drug product 2020-04-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211728-001 9040074 2031-01-20 Drug product 2020-04-29 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211728-001 9950069 2031-01-20 Drug product 2020-04-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211728-001 9040074 2031-01-20 Drug product 2020-04-29 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211728-001 9950069 2031-01-20 Drug product 2020-04-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211728-001 9040074 2031-01-20 Drug product 2020-04-29 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N211728-001 9950069 2031-01-20 Drug product 2020-04-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211728-001 9040074 2031-01-20 Drug product 2020-04-29 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211728-001 9950069 2031-01-20 Drug product 2020-04-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211728-001 9040074 2031-01-20 Drug product 2020-04-29 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211728-001 9950069 2031-01-20 Drug product 2020-04-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211728-001 9040074 2031-01-20 Drug product 2020-04-29 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211728-001 9950069 2031-01-20 Drug product 2020-04-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211728-001 9040074 2031-01-20 Drug product 2020-04-29 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N211728-001 9950069 2031-01-20 Drug product 2020-04-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211728-001 9040074 2031-01-20 Drug product 2020-04-29 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211728-001 9950069 2031-01-20 Drug product 2020-04-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211728-001 9040074 2031-01-20 Drug product 2020-04-29 5d02ea3f76ae…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 59 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 69605-103 JELMYTO mitomycin CENEXI - BLA NDA Current 72493-103 JELMYTO mitomycin UroGen Pharma, Inc. NDA Current 72493-103 JELMYTO mitomycin UroGen Pharma, Inc. NDA Current 72493-103 JELMYTO mitomycin UroGen Pharma, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 79829 SUPPL 2024-10-07 79826 SUPPL 2024-10-07 78476 SUPPL 2024-05-15 78475 SUPPL 2024-05-15 65933 SUPPL 2021-01-19 65911 SUPPL 2021-01-15 63482 ORIG 2020-06-11 62582 ORIG 2020-04-16 62580 ORIG 2020-04-15