Home Applications 201532 Application 201532
Type NDA
Sponsor EISAI INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 HALAVEN ERIBULIN MESYLATE SOLUTION;INTRAVENOUS 1MG/2ML (0.5MG/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 N201532-001 HALAVEN ERIBULIN MESYLATE 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-11-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N201532-001 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 N201532-001 RE46965 2027-01-08 Drug product 2018-08-07 N201532-001 RE46965*PED 2027-07-08 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N201532-001 M-280 2025-09-13 N201532-001 PED 2026-03-13
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 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-11-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-11-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-11-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-11-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-11-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-11-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-11-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-11-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-11-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-11-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-11-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-11-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-11-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS AP RLD, RS 2010-11-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-11-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-11-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-11-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-11-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-11-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-11-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-11-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-11-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-11-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-11-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-11-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-11-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-11-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-11-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-11-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-11-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-11-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-11-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-11-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-11-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-11-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-11-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-11-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-11-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-11-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N201532-001 HALAVEN 1MG/2ML (0.5MG/ML) SOLUTION / INTRAVENOUS RLD, RS 2010-11-15 cb3db0bc1861…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Patent history page 1 of 4 · 134 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 N201532-001 RE46965 2027-01-08 Drug product 2018-08-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N201532-001 RE46965*PED 2027-07-08 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201532-001 RE46965 2027-01-08 Drug product 2018-08-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N201532-001 RE46965*PED 2027-07-08 Pediatric extension 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N201532-001 RE46965 2027-01-08 Drug product 2018-08-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N201532-001 RE46965*PED 2027-07-08 Pediatric extension 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201532-001 RE46965 2027-01-08 Drug product 2018-08-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N201532-001 RE46965*PED 2027-07-08 Pediatric extension fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201532-001 RE46965 2027-01-08 Drug product 2018-08-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N201532-001 RE46965*PED 2027-07-08 Pediatric extension b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201532-001 6214865*PED 2024-01-20 Pediatric extension 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201532-001 RE46965 2027-01-08 Drug product 2018-08-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N201532-001 RE46965*PED 2027-07-08 Pediatric extension 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201532-001 6214865*PED 2024-01-20 Pediatric extension 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201532-001 RE46965 2027-01-08 Drug product 2018-08-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N201532-001 RE46965*PED 2027-07-08 Pediatric extension 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201532-001 6214865*PED 2024-01-20 Pediatric extension 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201532-001 RE46965 2027-01-08 Drug product 2018-08-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N201532-001 RE46965*PED 2027-07-08 Pediatric extension 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N201532-001 6214865*PED 2024-01-20 Pediatric extension d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N201532-001 RE46965 2027-01-08 Drug product 2018-08-07 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N201532-001 RE46965*PED 2027-07-08 Pediatric extension d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N201532-001 6214865*PED 2024-01-20 Pediatric extension d06236e962d9…2024-10-29 15:01 UTC 2024-10 N201532-001 RE46965 2027-01-08 Drug product 2018-08-07 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N201532-001 RE46965*PED 2027-07-08 Pediatric extension d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N201532-001 6214865*PED 2024-01-20 Pediatric extension 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N201532-001 RE46965 2027-01-08 Drug product 2018-08-07 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N201532-001 RE46965*PED 2027-07-08 Pediatric extension 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N201532-001 6214865*PED 2024-01-20 Pediatric extension 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N201532-001 RE46965 2027-01-08 Drug product 2018-08-07 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N201532-001 RE46965*PED 2027-07-08 Pediatric extension 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201532-001 6214865*PED 2024-01-20 Pediatric extension 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201532-001 RE46965 2027-01-08 Drug product 2018-08-07 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N201532-001 RE46965*PED 2027-07-08 Pediatric extension 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N201532-001 6214865*PED 2024-01-20 Pediatric extension 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N201532-001 RE46965 2027-01-08 Drug product 2018-08-07 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N201532-001 RE46965*PED 2027-07-08 Pediatric extension 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N201532-001 6214865 2023-07-20 Drug substance 2010-11-30 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N201532-001 RE46965 2027-01-08 Drug product 2018-08-07 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N201532-001 6214865 2023-07-20 Drug substance 2010-11-30 5d02ea3f76ae…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 78 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 · 2 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 17 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 43624-002 Halaven eribulin mesylate BSP Pharmaceuticals SpA NDA Current 43624-002 Halaven eribulin mesylate BSP Pharmaceuticals SpA NDA Current 43624-002 Halaven eribulin mesylate BSP Pharmaceuticals SpA NDA Current 43624-002 Halaven eribulin mesylate BSP Pharmaceuticals SpA NDA Current 62856-389 Halaven eribulin mesylate Eisai Inc. NDA Current 62856-389 Halaven eribulin mesylate Eisai Inc. NDA Current 62856-389 Halaven eribulin mesylate Eisai Inc. NDA Current 62856-389 Halaven eribulin mesylate Eisai Inc. NDA Current 62856-389 Halaven eribulin mesylate Eisai Inc. NDA Current 62856-389 Halaven eribulin mesylate Eisai Inc. NDA Current 62856-389 Halaven eribulin mesylate Eisai Inc. NDA Current 62856-389 Halaven eribulin mesylate Eisai Inc. NDA Current 62856-389 Halaven eribulin mesylate Eisai Inc. NDA Current 62856-389 Halaven eribulin mesylate Eisai Inc. NDA Current 62856-389 Halaven eribulin mesylate Eisai Inc. NDA Current 62856-389 Halaven eribulin mesylate Eisai Inc. NDA Current 62856-389 Halaven eribulin mesylate Eisai Inc. NDA Current