Home Applications 212295 Application 212295
Type NDA
Sponsor COSMO TECHNOLOGIES LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BYFAVO REMIMAZOLAM INJECTABLE;INJECTION 20MG Yes No
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 N212295-001 BYFAVO REMIMAZOLAM BESYLATE EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06
Orange Book patents# Current patent rows page 1 of 1 · 11 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N212295-001 10472365 2027-07-10 U-2968 2020-10-23 N212295-001 10961250 2027-07-10 U-2968 Drug product 2022-07-08 N212295-001 9777007 2027-07-10 Drug product 2020-10-23 N212295-001 9914738 2027-07-10 Drug product 2020-10-23 N212295-001 10052334 2031-11-07 U-2968 2020-10-23 N212295-001 10195210 2031-11-07 U-2968 2020-10-23 N212295-001 10342800 2031-11-07 U-2968 2020-10-23 N212295-001 10722522 2031-11-07 U-2968 2020-10-23 N212295-001 9737547 2031-11-07 U-2968 2020-10-23 N212295-001 9561236 2033-04-30 U-2968 2020-10-23 N212295-001 9827251 2034-01-13 U-2968 2020-10-23
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.
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 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-07-02 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N212295-001 BYFAVO EQ 20MG BASE/VIAL POWDER / INTRAVENOUS RLD, RS 2020-10-06 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 11 · 408 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 N212295-001 10472365 2027-07-10 U-2968 2020-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212295-001 10961250 2027-07-10 U-2968 Drug product 2022-07-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212295-001 9777007 2027-07-10 Drug product 2020-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212295-001 9914738 2027-07-10 Drug product 2020-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212295-001 10052334 2031-11-07 U-2968 2020-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212295-001 10195210 2031-11-07 U-2968 2020-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212295-001 10342800 2031-11-07 U-2968 2020-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212295-001 10722522 2031-11-07 U-2968 2020-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212295-001 9737547 2031-11-07 U-2968 2020-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212295-001 9561236 2033-04-30 U-2968 2020-10-23 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N212295-001 9827251 2034-01-13 U-2968 2020-10-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N212295-001 10472365 2027-07-10 U-2968 2020-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212295-001 10961250 2027-07-10 U-2968 Drug product 2022-07-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212295-001 9777007 2027-07-10 Drug product 2020-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212295-001 9914738 2027-07-10 Drug product 2020-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212295-001 10052334 2031-11-07 U-2968 2020-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212295-001 10195210 2031-11-07 U-2968 2020-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212295-001 10342800 2031-11-07 U-2968 2020-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212295-001 10722522 2031-11-07 U-2968 2020-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212295-001 9737547 2031-11-07 U-2968 2020-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212295-001 9561236 2033-04-30 U-2968 2020-10-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N212295-001 9827251 2034-01-13 U-2968 2020-10-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212295-001 10472365 2027-07-10 U-2968 2020-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212295-001 10961250 2027-07-10 U-2968 Drug product 2022-07-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212295-001 9777007 2027-07-10 Drug product 2020-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212295-001 9914738 2027-07-10 Drug product 2020-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212295-001 10052334 2031-11-07 U-2968 2020-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212295-001 10195210 2031-11-07 U-2968 2020-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212295-001 10342800 2031-11-07 U-2968 2020-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212295-001 10722522 2031-11-07 U-2968 2020-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212295-001 9737547 2031-11-07 U-2968 2020-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212295-001 9561236 2033-04-30 U-2968 2020-10-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N212295-001 9827251 2034-01-13 U-2968 2020-10-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N212295-001 10472365 2027-07-10 U-2968 2020-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212295-001 10961250 2027-07-10 U-2968 Drug product 2022-07-08 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212295-001 9777007 2027-07-10 Drug product 2020-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212295-001 9914738 2027-07-10 Drug product 2020-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212295-001 10052334 2031-11-07 U-2968 2020-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212295-001 10195210 2031-11-07 U-2968 2020-10-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N212295-001 10342800 2031-11-07 U-2968 2020-10-23 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join BYFAVO REMIMAZOLAM BESYLATE Acacia Pharma, Ltd. 4e1838f2-b999-41a7-a761-d94f09aa531f 2025-02-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 212295 application number: NDA212295 ndc (product): 71390-011
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 5 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 71390-011 BYFAVO remimazolam besylate Acacia Pharma Ltd NDA Current 71390-011 BYFAVO remimazolam besylate Acacia Pharma, Ltd. NDA Current 71390-011 BYFAVO remimazolam besylate Acacia Pharma Ltd NDA Current 71390-011 BYFAVO remimazolam besylate Acacia Pharma, Ltd. NDA Current 71390-011 BYFAVO remimazolam besylate Acacia Pharma, Ltd. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 73216 SUPPL 2023-01-17 68930 ORIG 2021-10-08 67024 SUPPL 2021-04-12 67011 SUPPL 2021-04-09 65450 SUPPL 2020-12-01 65440 SUPPL 2020-12-01 64155 ORIG 2020-07-31 63794 ORIG 2020-07-06 63788 ORIG 2020-07-02