Home Applications 210598 Application 210598
Type NDA
Sponsor MYLAN IRELAND LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 YUPELRI REVEFENACIN SOLUTION;INHALATION 175MCG/3ML Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N210598-001 YUPELRI REVEFENACIN 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09
Orange Book patents# Current patent rows page 1 of 1 · 10 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N210598-001 7288657 2028-10-31 Drug substance 2018-11-20 N210598-001 10550081 2030-07-14 Drug substance 2020-02-10 N210598-001 11008289 2030-07-14 U-2440 2021-05-20 N210598-001 11691948 2030-07-14 Drug product 2023-07-05 N210598-001 11858898 2030-07-14 U-2440 Drug substance, Drug product 2024-01-02 N210598-001 9765028 2030-07-14 Drug substance 2019-05-31 N210598-001 8541451 2031-08-25 Drug substance 2019-05-31 N210598-001 12048692 2039-08-29 U-2440 2024-07-30 N210598-001 12285417 2039-08-29 U-2440 2025-04-30 N210598-001 11484531 2039-10-23 U-2440 2022-11-02
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.
Product history page 1 of 2 · 41 observed 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 2026-02-19 14:30 UTC 2026-02 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N210598-001 YUPELRI 175MCG/3ML SOLUTION / INHALATION RLD, RS 2018-11-09 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 18 · 690 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N210598-001 7288657 2028-10-31 Drug substance 2018-11-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210598-001 10550081 2030-07-14 Drug substance 2020-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210598-001 11008289 2030-07-14 U-2440 2021-05-20 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210598-001 11691948 2030-07-14 Drug product 2023-07-05 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210598-001 11858898 2030-07-14 U-2440 Drug substance, Drug product 2024-01-02 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210598-001 9765028 2030-07-14 Drug substance 2019-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210598-001 8541451 2031-08-25 Drug substance 2019-05-31 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210598-001 12048692 2039-08-29 U-2440 2024-07-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210598-001 12285417 2039-08-29 U-2440 2025-04-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N210598-001 11484531 2039-10-23 U-2440 2022-11-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 10106503 2025-03-10 U-2440 2018-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 10343995 2025-03-10 U-2440 2019-07-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 11247969 2025-03-10 Drug product 2022-03-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 7491736 2025-03-10 U-2440 2018-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 7521041 2025-03-10 U-2440 2018-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 7550595 2025-03-10 Drug product 2018-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 7585879 2025-03-10 U-2440 Drug substance, Drug product 2018-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 7910608 2025-03-10 Drug substance, Drug product 2018-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 8034946 2025-03-10 Drug product 2018-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 8053448 2025-03-10 U-2440 2018-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 8273894 2025-03-10 Drug product 2018-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 7288657 2028-10-31 Drug substance 2018-11-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 10550081 2030-07-14 Drug substance 2020-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 11008289 2030-07-14 U-2440 2021-05-20 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 11691948 2030-07-14 Drug product 2023-07-05 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 11858898 2030-07-14 U-2440 Drug substance, Drug product 2024-01-02 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 9765028 2030-07-14 Drug substance 2019-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 8541451 2031-08-25 Drug substance 2019-05-31 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 12048692 2039-08-29 U-2440 2024-07-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 12285417 2039-08-29 U-2440 2025-04-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N210598-001 11484531 2039-10-23 U-2440 2022-11-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N210598-001 10106503 2025-03-10 U-2440 2018-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210598-001 10343995 2025-03-10 U-2440 2019-07-15 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210598-001 11247969 2025-03-10 Drug product 2022-03-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210598-001 7491736 2025-03-10 U-2440 2018-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210598-001 7521041 2025-03-10 U-2440 2018-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210598-001 7550595 2025-03-10 Drug product 2018-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210598-001 7585879 2025-03-10 U-2440 Drug substance, Drug product 2018-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210598-001 7910608 2025-03-10 Drug substance, Drug product 2018-11-20 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N210598-001 8034946 2025-03-10 Drug product 2018-11-20 6a471c1ec25d…
Observed Orange Book exclusivity history# 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 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 49502-806 YUPELRI revefenacin Mylan Specialty L.P. NDA Current 49502-806 YUPELRI revefenacin Mylan Specialty L.P. NDA Current 49502-806 YUPELRI revefenacin Mylan Specialty L.P. NDA Current 49502-806 YUPELRI revefenacin Mylan Specialty L.P. NDA Current 49502-806 YUPELRI revefenacin Mylan Specialty L.P. NDA Current 49502-806 YUPELRI revefenacin Mylan Specialty L.P. NDA Current 49502-806 YUPELRI revefenacin Mylan Specialty L.P. NDA Current 49502-806 YUPELRI revefenacin Mylan Specialty L.P. NDA Current 49502-806 YUPELRI revefenacin Mylan Specialty L.P. NDA Current 49502-806 YUPELRI revefenacin Mylan Specialty L.P. NDA Current 49502-806 YUPELRI revefenacin Mylan Specialty L.P. NDA Current 49502-806 YUPELRI revefenacin Mylan Specialty L.P. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 71154 SUPPL 2022-05-26 71151 SUPPL 2022-05-26 69266 SUPPL 2021-11-05 58829 SUPPL 2019-05-22 58827 SUPPL 2019-05-22 56752 ORIG 2018-12-17 56429 ORIG 2018-11-14 56399 ORIG 2018-11-09 56398 ORIG 2018-11-09