Home Applications 209401 Application 209401
Type NDA
Sponsor CELATOR PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 VYXEOS CYTARABINE; DAUNORUBICIN POWDER;INTRAVENOUS 100MG;44MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 N209401-001 VYXEOS CYTARABINE; DAUNORUBICIN 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03
Orange Book patents# Current patent rows page 1 of 1 · 16 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209401-001 8518437 2026-06-07 Drug product 2017-08-30 N209401-001 7850990 2027-01-23 U-3147 Drug product 2017-08-30 N209401-001 9271931 2027-01-23 Drug product 2017-08-30 N209401-001 7850990*PED 2027-07-23 Pediatric extension N209401-001 9271931*PED 2027-07-23 Pediatric extension N209401-001 8022279 2027-09-14 U-3147 Drug product 2017-08-30 N209401-001 8022279*PED 2028-03-14 Pediatric extension N209401-001 8092828 2029-04-01 U-3147 2017-08-30 N209401-001 8092828*PED 2029-10-01 Pediatric extension N209401-001 10028912 2032-10-15 U-3149 Drug product 2018-08-06 N209401-001 10028912 2032-10-15 U-3150 Drug product 2018-08-06 N209401-001 10166184 2032-10-15 U-3149 Drug product 2019-02-25 N209401-001 10835492 2032-10-15 U-3150 2020-12-08 N209401-001 10028912*PED 2033-04-15 Pediatric extension N209401-001 10166184*PED 2033-04-15 Pediatric extension N209401-001 10835492*PED 2033-04-15 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 N209401-001 ODE-350 2028-03-30 N209401-001 PED 2028-09-30
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 · 42 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 2026-08-18 06:07:40 2026-07 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N209401-001 VYXEOS 100MG;44MG POWDER / INTRAVENOUS RLD, RS 2017-08-03 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 11 · 433 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-08-18 06:07:40 2026-07 N209401-001 8518437 2026-06-07 Drug product 2017-08-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209401-001 7850990 2027-01-23 U-3147 Drug product 2017-08-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209401-001 9271931 2027-01-23 Drug product 2017-08-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209401-001 7850990*PED 2027-07-23 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209401-001 9271931*PED 2027-07-23 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209401-001 8022279 2027-09-14 U-3147 Drug product 2017-08-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209401-001 8022279*PED 2028-03-14 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209401-001 8092828 2029-04-01 U-3147 2017-08-30 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209401-001 8092828*PED 2029-10-01 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209401-001 10028912 2032-10-15 U-3150 Drug product 2018-08-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209401-001 10028912 2032-10-15 U-3149 Drug product 2018-08-06 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209401-001 10166184 2032-10-15 U-3149 Drug product 2019-02-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209401-001 10835492 2032-10-15 U-3150 2020-12-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209401-001 10028912*PED 2033-04-15 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209401-001 10166184*PED 2033-04-15 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N209401-001 10835492*PED 2033-04-15 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N209401-001 8518437 2026-06-07 Drug product 2017-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209401-001 7850990 2027-01-23 U-3147 Drug product 2017-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209401-001 9271931 2027-01-23 Drug product 2017-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209401-001 7850990*PED 2027-07-23 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209401-001 9271931*PED 2027-07-23 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209401-001 8022279 2027-09-14 U-3147 Drug product 2017-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209401-001 8022279*PED 2028-03-14 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209401-001 8092828 2029-04-01 U-3147 2017-08-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209401-001 8092828*PED 2029-10-01 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209401-001 10028912 2032-10-15 U-3150 Drug product 2018-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209401-001 10028912 2032-10-15 U-3149 Drug product 2018-08-06 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209401-001 10166184 2032-10-15 U-3149 Drug product 2019-02-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209401-001 10835492 2032-10-15 U-3150 2020-12-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209401-001 10028912*PED 2033-04-15 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209401-001 10166184*PED 2033-04-15 Pediatric extension 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209401-001 10835492*PED 2033-04-15 Pediatric extension 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209401-001 8431806 2025-04-22 U-3147 Drug product 2017-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209401-001 8518437 2026-06-07 Drug product 2017-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209401-001 7850990 2027-01-23 U-3147 Drug product 2017-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209401-001 9271931 2027-01-23 Drug product 2017-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209401-001 8022279 2027-09-14 U-3147 Drug product 2017-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209401-001 8092828 2029-04-01 U-3147 2017-08-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209401-001 10028912 2032-10-15 U-3150 Drug product 2018-08-06 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209401-001 10028912 2032-10-15 U-3149 Drug product 2018-08-06 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 3 · 101 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join VYXEOS (DAUNORUBICIN AND CYTARABINE) LIPOSOME Jazz Pharmaceuticals, Inc. 7ea701ce-e7d3-4349-a9c2-642a501d45c8 2026-01-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 209401 application number: NDA209401 ndc (product): 68727-745
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 68727-745 VYXEOS (daunorubicin and cytarabine) liposome Jazz Pharmaceuticals, Inc. NDA Current 68727-745 VYXEOS (daunorubicin and cytarabine) liposome Jazz Pharmaceuticals, Inc. NDA Current 68727-745 VYXEOS (daunorubicin and cytarabine) liposome Jazz Pharmaceuticals, Inc. NDA Current 68727-745 VYXEOS (daunorubicin and cytarabine) liposome Jazz Pharmaceuticals, Inc. NDA Current 68727-745 VYXEOS (daunorubicin and cytarabine) liposome Jazz Pharmaceuticals, Inc. NDA Current 68727-745 VYXEOS (daunorubicin and cytarabine) liposome Jazz Pharmaceuticals, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 84859 SUPPL 2026-01-28 84849 SUPPL 2026-01-28 72174 SUPPL 2022-09-28 72169 SUPPL 2022-09-28 66933 SUPPL 2021-03-31 66924 SUPPL 2021-03-30 61559 SUPPL 2020-01-14 53816 ORIG 2018-04-25 49243 ORIG 2017-08-04 49218 ORIG 2017-08-03