Application 206256

Type: NDA
Sponsor: ACROTECH

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BELEODAQ	BELINOSTAT	POWDER;INTRAVENOUS	500MG/VIAL	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
N206256-001	BELEODAQ	BELINOSTAT	500MG/VIAL	POWDER / INTRAVENOUS		RLD, RS	2014-07-03

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
N206256-001	6888027	2026-08-10	U-1544	Drug substance, Drug product	2014-08-01
N206256-001	8835501	2027-10-27		Drug product	2014-10-09

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N206256-001	BELEODAQ	500MG/VIAL	POWDER / INTRAVENOUS	RLD, RS	2014-07-03	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 82 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	N206256-001	6888027	2026-08-10	U-1544	Drug substance, Drug product	2014-08-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N206256-001	8835501	2027-10-27		Drug product	2014-10-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206256-001	6888027	2026-08-10	U-1544	Drug substance, Drug product	2014-08-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N206256-001	8835501	2027-10-27		Drug product	2014-10-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N206256-001	6888027	2026-08-10	U-1544	Drug substance, Drug product	2014-08-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N206256-001	8835501	2027-10-27		Drug product	2014-10-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206256-001	6888027	2026-08-10	U-1544	Drug substance, Drug product	2014-08-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N206256-001	8835501	2027-10-27		Drug product	2014-10-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206256-001	6888027	2026-08-10	U-1544	Drug substance, Drug product	2014-08-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N206256-001	8835501	2027-10-27		Drug product	2014-10-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206256-001	6888027	2026-08-10	U-1544	Drug substance, Drug product	2014-08-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N206256-001	8835501	2027-10-27		Drug product	2014-10-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206256-001	6888027	2026-08-10	U-1544	Drug substance, Drug product	2014-08-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N206256-001	8835501	2027-10-27		Drug product	2014-10-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206256-001	6888027	2026-08-10	U-1544	Drug substance, Drug product	2014-08-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N206256-001	8835501	2027-10-27		Drug product	2014-10-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206256-001	6888027	2026-08-10	U-1544	Drug substance, Drug product	2014-08-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N206256-001	8835501	2027-10-27		Drug product	2014-10-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N206256-001	6888027	2026-08-10	U-1544	Drug substance, Drug product	2014-08-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N206256-001	8835501	2027-10-27		Drug product	2014-10-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206256-001	6888027	2026-08-10	U-1544	Drug substance, Drug product	2014-08-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N206256-001	8835501	2027-10-27		Drug product	2014-10-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206256-001	6888027	2026-08-10	U-1544	Drug substance, Drug product	2014-08-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N206256-001	8835501	2027-10-27		Drug product	2014-10-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206256-001	6888027	2026-08-10	U-1544	Drug substance, Drug product	2014-08-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N206256-001	8835501	2027-10-27		Drug product	2014-10-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N206256-001	6888027	2026-08-10	U-1544	Drug substance, Drug product	2014-08-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N206256-001	8835501	2027-10-27		Drug product	2014-10-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206256-001	6888027	2026-08-10	U-1544	Drug substance, Drug product	2014-08-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N206256-001	8835501	2027-10-27		Drug product	2014-10-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N206256-001	6888027	2026-08-10	U-1544	Drug substance, Drug product	2014-08-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N206256-001	8835501	2027-10-27		Drug product	2014-10-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N206256-001	6888027	2026-08-10	U-1544	Drug substance, Drug product	2014-08-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N206256-001	8835501	2027-10-27		Drug product	2014-10-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N206256-001	6888027	2021-09-27	U-1544	Drug substance, Drug product	2014-08-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206256-001	8835501	2027-10-27		Drug product	2014-10-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N206256-001	6888027	2026-08-10	U-1544	Drug substance, Drug product	2014-08-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N206256-001	8835501	2027-10-27		Drug product	2014-10-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N206256-001	6888027	2026-08-10	U-1544	Drug substance, Drug product	2014-08-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N206256-001	8835501	2027-10-27		Drug product	2014-10-09	`782e0a99824c…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N206256-001	NCE	2019-07-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N206256-001	ODE-68	2021-07-03	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N206256-001	ODE-68	2021-07-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N206256-001	ODE-68	2021-07-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N206256-001	ODE-68	2021-07-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N206256-001	ODE-68	2021-07-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N206256-001	ODE-68	2021-07-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N206256-001	NCE	2019-07-03	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N206256-001	ODE-68	2021-07-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N206256-001	NCE	2019-07-03	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N206256-001	ODE-68	2021-07-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N206256-001	NCE	2019-07-03	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N206256-001	ODE-68	2021-07-03	`ea99ee380514…`

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
Beleodaq	BELINOSTAT	Acrotech Biopharma Inc	2e8ef36b-71fa-4492-a16f-577d5f7d111d	2025-04-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 206256 application number: NDA206256 ndc (product): 72893-002

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68152-108	Beleodaq	Belinostat	Spectrum Pharmaceuticals, Inc.	NDA	Current
68152-108	Beleodaq	Belinostat	Acrotech Biopharma LLC	NDA	Current
68152-108	Beleodaq	Belinostat	Spectrum Pharmaceuticals, Inc.	NDA	Current
69605-002	Beleodaq	Belinostat	CENEXI - BLA	NDA	Current
72893-002	Beleodaq	Belinostat	Acrotech Biopharma LLC	NDA	Current
72893-002	Beleodaq	Belinostat	Acrotech Biopharma LLC	NDA	Current
72893-002	Beleodaq	Belinostat	Acrotech Biopharma LLC	NDA	Current
72893-002	Beleodaq	Belinostat	Acrotech Biopharma LLC	NDA	Current
72893-002	Beleodaq	Belinostat	Acrotech Biopharma Inc	NDA	Current
72893-002	Beleodaq	Belinostat	Acrotech Biopharma LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80257	SUPPL	2024-11-21
80248	SUPPL	2024-11-21
70799	SUPPL	2022-04-22
70798	SUPPL	2022-04-21
61546	SUPPL	2020-01-10
61539	SUPPL	2020-01-09
48035	SUPPL	2017-04-14
48003	SUPPL	2017-04-13
44939	ORIG	2014-08-05
23017	ORIG	2014-08-05
32787	ORIG	2014-07-03
40532	ORIG	2014-07-02