Application 211241

Type: NDA
Sponsor: SENTYNL THERAPS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZYCUBO	COPPER HISTIDINATE	POWDER;SUBCUTANEOUS	2.9MG/VIAL	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
N211241-001	ZYCUBO	COPPER HISTIDINATE	2.9MG/VIAL	POWDER / SUBCUTANEOUS		RLD, RS	2026-01-12

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N211241-001	NCE	2031-01-12
N211241-001	ODE-520	2033-01-12

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N211241-001	ZYCUBO	2.9MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2026-01-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211241-001	ZYCUBO	2.9MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2026-01-12	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N211241-001	ZYCUBO	2.9MG/VIAL	POWDER / SUBCUTANEOUS	RLD, RS	2026-01-12	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N211241-001	NCE	2031-01-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N211241-001	ODE-520	2033-01-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N211241-001	NCE	2031-01-12	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N211241-001	NCE	2031-01-12	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N211241-001	ODE-520	2033-01-12	`a50c72e98297…`

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
Zycubo	COPPER HISTIDINATE	Sentynl Therapeutics, Inc.	e3aeefc2-f44d-4337-9c2e-3dba44a89e48	2026-01-12	Warnings, Adverse reactions	Exact identifier application applno (NDA): 211241 application number: NDA211241

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85012	ORIG	2026-02-12
84742	ORIG	2026-01-13
84735	ORIG	2026-01-12