Beleodaq

Product NDC: 68152-108
Requested package NDC: 68152-108-09
11-digit product format: 681520108
Labeler code: 68152
Product ID: 68152-108_a3eb9a59-72c3-4c99-b0e7-0dad901695a0
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Belinostat
Dosage form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Acrotech Biopharma LLC
Application: NDA206256
Marketing category: NDA
Marketing start: 2014-07-21
Marketing end: 0000-00-00
Substance: BELINOSTAT
Active strength: 500 mg/10mL
Pharmacologic classes: Histone Deacetylase Inhibitor [EPC],Histone Deacetylase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68152-108	68152-108-09	D	Discontinued by firm		2026-08-11

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68152-108-09	2023-04-18	C162847	48780-1	f386c649-b702-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use BELEODAQ safely and effectively. See full prescribing information for BELEODAQ. BELEODAQ® (belinostat) for injection, for intravenous use Initial U.S. Approval: 2014
68152-108-09	2023-01-30	C162847	48780-1	f386c649-b702-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use BELEODAQ safely and effectively. See full prescribing information for BELEODAQ. BELEODAQ® (belinostat) for injection, for intravenous use Initial U.S. Approval: 2014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68152-108-09	EA - Each	68152-108	13eb84a2-4f01-4fe0-8696-8eb4b0cf5c1f	1	2014-08-01

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BELINOSTAT	ACTIVE INGREDIENT	F4H96P17NZ	BELEODAQ (BELINOSTAT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SPECTRUM PHARMACEUTICALS, INC.]	2
BELINOSTAT	ACTIVE MOIETY	F4H96P17NZ	BELEODAQ (BELINOSTAT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SPECTRUM PHARMACEUTICALS, INC.]	2
ARGININE	INACTIVE INGREDIENT	94ZLA3W45F	BELEODAQ (BELINOSTAT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [SPECTRUM PHARMACEUTICALS, INC.]	2

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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F4H96P17NZ	BELINOSTAT	866323-14-0	BELINOSTAT

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68152-108-09	68152010809	1 VIAL, SINGLE-DOSE in 1 CARTON (68152-108-09) > 10 mL in 1 VIAL, SINGLE-DOSE	2014-07-21	2022-11-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Beleodaq	Acrotech Biopharma LLC \| Spectrum Pharmaceuticals, Inc.	2021-12-29	Human Prescription Drug Label	9