Home Applications 022161 Application 022161
Type NDA
Sponsor ASTELLAS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LEXISCAN REGADENOSON SOLUTION;INTRAVENOUS 0.4MG/5ML (0.08MG/ML) 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 N022161-001 LEXISCAN REGADENOSON 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N022161-001 AP
Orange Book patents# Current patent rows page 1 of 1 · 2 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N022161-001 8106183 2027-02-02 Drug substance 2012-03-08 N022161-001 RE47301 2027-02-02 Drug product 2019-04-02
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 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2008-04-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2008-04-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2008-04-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2008-04-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2008-04-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2008-04-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2008-04-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2008-04-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2008-04-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2008-04-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2008-04-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2008-04-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N022161-001 LEXISCAN 0.4MG/5ML (0.08MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2008-04-10 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 5 · 172 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 N022161-001 8106183 2027-02-02 Drug substance 2012-03-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N022161-001 RE47301 2027-02-02 Drug product 2019-04-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022161-001 8106183 2027-02-02 Drug substance 2012-03-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N022161-001 RE47301 2027-02-02 Drug product 2019-04-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N022161-001 8106183 2027-02-02 Drug substance 2012-03-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N022161-001 RE47301 2027-02-02 Drug product 2019-04-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022161-001 8106183 2027-02-02 Drug substance 2012-03-08 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N022161-001 RE47301 2027-02-02 Drug product 2019-04-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022161-001 8106183 2027-02-02 Drug substance 2012-03-08 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N022161-001 RE47301 2027-02-02 Drug product 2019-04-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022161-001 8106183 2027-02-02 Drug substance 2012-03-08 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N022161-001 RE47301 2027-02-02 Drug product 2019-04-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022161-001 8106183 2027-02-02 Drug substance 2012-03-08 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N022161-001 RE47301 2027-02-02 Drug product 2019-04-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022161-001 8106183 2027-02-02 Drug substance 2012-03-08 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N022161-001 RE47301 2027-02-02 Drug product 2019-04-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022161-001 8106183 2027-02-02 Drug substance 2012-03-08 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N022161-001 RE47301 2027-02-02 Drug product 2019-04-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N022161-001 8106183 2027-02-02 Drug substance 2012-03-08 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N022161-001 RE47301 2027-02-02 Drug product 2019-04-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022161-001 8106183 2027-02-02 Drug substance 2012-03-08 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N022161-001 RE47301 2027-02-02 Drug product 2019-04-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022161-001 8106183 2027-02-02 Drug substance 2012-03-08 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N022161-001 RE47301 2027-02-02 Drug product 2019-04-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022161-001 8106183 2027-02-02 Drug substance 2012-03-08 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N022161-001 RE47301 2027-02-02 Drug product 2019-04-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N022161-001 8106183 2027-02-02 Drug substance 2012-03-08 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N022161-001 RE47301 2027-02-02 Drug product 2019-04-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022161-001 6403567 2022-04-10 U-869 Drug substance, Drug product 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022161-001 8106183 2027-02-02 Drug substance 2012-03-08 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N022161-001 RE47301 2027-02-02 Drug product 2019-04-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N022161-001 6403567 2022-04-10 U-869 Drug substance, Drug product 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022161-001 8106183 2027-02-02 Drug substance 2012-03-08 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N022161-001 RE47301 2027-02-02 Drug product 2019-04-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N022161-001 6403567 2022-04-10 U-869 Drug substance, Drug product 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022161-001 8106183 2027-02-02 Drug substance 2012-03-08 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N022161-001 RE47301 2027-02-02 Drug product 2019-04-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N022161-001 7144872 2019-06-22 U-870 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022161-001 7144872 2019-06-22 U-116 Drug substance, Drug product 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N022161-001 7144872 2019-06-22 U-869 Drug substance, Drug product 74a2ff9319b5…
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 · 2 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 0469-6501 LEXISCAN regadenoson Astellas Pharma US, Inc. NDA Current 51662-1448 LEXISCAN(R) (REGADENOSON) LEXISCAN(R) (REGADENOSON) HF Acquisition Co LLC, DBA HealthFirst NDA Current 51662-1448 LEXISCAN(R) (REGADENOSON) LEXISCAN(R) (REGADENOSON) HF Acquisition Co LLC, DBA HealthFirst NDA Current 51662-1448 LEXISCAN(R) (REGADENOSON) LEXISCAN(R) (REGADENOSON) HF Acquisition Co LLC, DBA HealthFirst NDA Current