Home Applications 214410 Application 214410
Type NDA
Sponsor GENENTECH INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 XOFLUZA BALOXAVIR MARBOXIL TABLET;ORAL 20MG Yes No 002 XOFLUZA BALOXAVIR MARBOXIL TABLET;ORAL 40MG Yes No 003 XOFLUZA BALOXAVIR MARBOXIL SUSPENSION;ORAL 40MG/20ML Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N214410-001 XOFLUZA BALOXAVIR MARBOXIL 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 N214410-002 XOFLUZA BALOXAVIR MARBOXIL 30MG/PACKET FOR SUSPENSION / ORAL RLD 2025-05-30 N214410-003 XOFLUZA BALOXAVIR MARBOXIL 40MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2025-05-30
Orange Book patents# Current patent rows page 1 of 1 · 33 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N214410-001 9815835 2030-06-14 Drug product 2020-12-17 N214410-001 8927710 2031-05-05 Drug product 2020-12-17 N214410-001 8987441 2032-10-24 Drug substance, Drug product 2020-12-17 N214410-001 10392406 2036-04-27 Drug substance 2020-12-17 N214410-001 10633397 2036-04-27 U-2816 2020-12-17 N214410-001 10633397 2036-04-27 U-3000 2020-12-17 N214410-001 10759814 2037-08-09 Drug substance, Drug product 2020-12-17 N214410-001 11306106 2037-08-09 U-2816 2022-05-17 N214410-001 11306106 2037-08-09 U-3000 2022-05-17 N214410-001 11261198 2038-09-25 Drug product 2022-04-04 N214410-001 11925648 2041-04-21 Drug product 2024-03-28 N214410-002 9815835 2030-06-14 Drug product 2025-06-26 N214410-002 8927710 2031-05-05 Drug product 2025-06-26 N214410-002 8987441 2032-10-24 Drug substance, Drug product 2025-06-26 N214410-002 10392406 2036-04-27 Drug substance 2025-06-26 N214410-002 10633397 2036-04-27 U-2816 2025-06-26 N214410-002 10633397 2036-04-27 U-3000 2025-06-26 N214410-002 10759814 2037-08-09 Drug substance, Drug product 2025-06-26 N214410-002 11306106 2037-08-09 U-2816 2025-06-26 N214410-002 11306106 2037-08-09 U-3000 2025-06-26 N214410-002 11261198 2038-09-25 Drug product 2025-06-26 N214410-002 11925648 2041-04-21 Drug product 2025-06-26 N214410-003 9815835 2030-06-14 Drug product 2025-06-26 N214410-003 8927710 2031-05-05 Drug product 2025-06-26 N214410-003 8987441 2032-10-24 Drug substance, Drug product 2025-06-26 N214410-003 10392406 2036-04-27 Drug substance 2025-06-26 N214410-003 10633397 2036-04-27 U-2816 2025-06-26 N214410-003 10633397 2036-04-27 U-3000 2025-06-26 N214410-003 10759814 2037-08-09 Drug substance, Drug product 2025-06-26 N214410-003 11306106 2037-08-09 U-2816 2025-06-26 N214410-003 11306106 2037-08-09 U-3000 2025-06-26 N214410-003 11261198 2038-09-25 Drug product 2025-06-26 N214410-003 11925648 2041-04-21 Drug product 2025-06-26
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 3 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N214410-001 M-187 2027-12-19 N214410-002 M-187 2027-12-19 N214410-003 M-187 2027-12-19
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 · 44 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 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-002 XOFLUZA 30MG/PACKET FOR SUSPENSION / ORAL RLD 2025-05-30 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-003 XOFLUZA 40MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2025-05-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214410-002 XOFLUZA 30MG/PACKET FOR SUSPENSION / ORAL RLD 2025-05-30 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214410-003 XOFLUZA 40MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2025-05-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214410-002 XOFLUZA 30MG/PACKET FOR SUSPENSION / ORAL RLD 2025-05-30 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N214410-003 XOFLUZA 40MG/PACKET FOR SUSPENSION / ORAL RLD, RS 2025-05-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 8869cabd3fbd…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N214410-001 XOFLUZA 2MG/ML FOR SUSPENSION / ORAL RLD, RS 2020-11-23 e64feba35796…
Observed Orange Book patent history# Patent history page 1 of 11 · 436 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 N214410-001 9815835 2030-06-14 Drug product 2020-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-001 8927710 2031-05-05 Drug product 2020-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-001 8987441 2032-10-24 Drug substance, Drug product 2020-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-001 10392406 2036-04-27 Drug substance 2020-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-001 10633397 2036-04-27 U-2816 2020-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-001 10633397 2036-04-27 U-3000 2020-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-001 10759814 2037-08-09 Drug substance, Drug product 2020-12-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-001 11306106 2037-08-09 U-2816 2022-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-001 11306106 2037-08-09 U-3000 2022-05-17 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-001 11261198 2038-09-25 Drug product 2022-04-04 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-001 11925648 2041-04-21 Drug product 2024-03-28 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-002 9815835 2030-06-14 Drug product 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-002 8927710 2031-05-05 Drug product 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-002 8987441 2032-10-24 Drug substance, Drug product 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-002 10392406 2036-04-27 Drug substance 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-002 10633397 2036-04-27 U-3000 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-002 10633397 2036-04-27 U-2816 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-002 10759814 2037-08-09 Drug substance, Drug product 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-002 11306106 2037-08-09 U-3000 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-002 11306106 2037-08-09 U-2816 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-002 11261198 2038-09-25 Drug product 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-002 11925648 2041-04-21 Drug product 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-003 9815835 2030-06-14 Drug product 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-003 8927710 2031-05-05 Drug product 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-003 8987441 2032-10-24 Drug substance, Drug product 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-003 10392406 2036-04-27 Drug substance 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-003 10633397 2036-04-27 U-3000 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-003 10633397 2036-04-27 U-2816 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-003 10759814 2037-08-09 Drug substance, Drug product 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-003 11306106 2037-08-09 U-2816 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-003 11306106 2037-08-09 U-3000 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-003 11261198 2038-09-25 Drug product 2025-06-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N214410-003 11925648 2041-04-21 Drug product 2025-06-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214410-001 9815835 2030-06-14 Drug product 2020-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214410-001 8927710 2031-05-05 Drug product 2020-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214410-001 8987441 2031-09-21 Drug substance, Drug product 2020-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214410-001 10392406 2036-04-27 Drug substance 2020-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214410-001 10633397 2036-04-27 U-2816 2020-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214410-001 10633397 2036-04-27 U-3000 2020-12-17 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N214410-001 10759814 2037-08-09 Drug substance, Drug product 2020-12-17 31067a03dcf5…
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Xofluza BALOXAVIR MARBOXIL Genentech, Inc. e49e1a61-1b7c-4be5-ac84-af6240b511e7 2025-12-15 Warnings, Adverse reactions Exact identifier application applno (NDA): 214410 application number: NDA214410