Application 219947

Type: NDA
Sponsor: ARROWHEAD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	REDEMPLO	PLOZASIRAN SODIUM	SOLUTION;SUBCUTANEOUS	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N219947-001	REDEMPLO	PLOZASIRAN SODIUM	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2025-11-18

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N219947-001	10294474	2037-03-07	U-4360	Drug substance, Drug product	2025-12-17
N219947-001	11174481	2037-03-07		Drug substance, Drug product	2025-12-17
N219947-001	10597657	2038-09-10	U-4360	Drug substance, Drug product	2025-12-17
N219947-001	11214801	2038-09-10	U-4360	Drug substance, Drug product	2025-12-17
N219947-001	12365899	2038-09-10	U-4360	Drug substance, Drug product	2025-12-17

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219947-001	ODE-541	2032-11-18

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
2026-09-14 22:38:34	2026-08	N219947-001	REDEMPLO	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2025-11-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219947-001	REDEMPLO	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2025-11-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219947-001	REDEMPLO	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2025-11-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219947-001	REDEMPLO	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2025-11-18	`31067a03dcf5…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219947-001	REDEMPLO	EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2025-11-18	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N219947-001	10294474	2037-03-07	U-4360	Drug substance, Drug product	2025-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219947-001	11174481	2037-03-07		Drug substance, Drug product	2025-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219947-001	10597657	2038-09-10	U-4360	Drug substance, Drug product	2025-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219947-001	11214801	2038-09-10	U-4360	Drug substance, Drug product	2025-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219947-001	12365899	2038-09-10	U-4360	Drug substance, Drug product	2025-12-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219947-001	10294474	2037-03-07	U-4360	Drug substance, Drug product	2025-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219947-001	11174481	2037-03-07		Drug substance, Drug product	2025-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219947-001	10597657	2038-09-10	U-4360	Drug substance, Drug product	2025-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219947-001	11214801	2038-09-10	U-4360	Drug substance, Drug product	2025-12-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219947-001	12365899	2038-09-10	U-4360	Drug substance, Drug product	2025-12-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219947-001	10294474	2037-03-07	U-4360	Drug substance, Drug product	2025-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219947-001	11174481	2037-03-07		Drug substance, Drug product	2025-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219947-001	10597657	2038-09-10	U-4360	Drug substance, Drug product	2025-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219947-001	11214801	2038-09-10	U-4360	Drug substance, Drug product	2025-12-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219947-001	12365899	2038-09-10	U-4360	Drug substance, Drug product	2025-12-17	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219947-001	10294474	2037-03-07	U-4360	Drug substance, Drug product	2025-12-17	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219947-001	11174481	2037-03-07		Drug substance, Drug product	2025-12-17	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219947-001	10597657	2038-09-10	U-4360	Drug substance, Drug product	2025-12-17	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219947-001	11214801	2038-09-10	U-4360	Drug substance, Drug product	2025-12-17	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219947-001	12365899	2038-09-10	U-4360	Drug substance, Drug product	2025-12-17	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N219947-001	ODE-541	2032-11-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219947-001	ODE-541	2032-11-18	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219947-001	ODE-541	2032-11-18	`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
REDEMPLO	PLOZASIRAN	Arrowhead Pharmaceuticals, Inc.	7fd37993-f85a-4af1-8bbe-133299f226ed	2026-08-25	Adverse reactions	Exact identifier application applno (NDA): 219947 application number: NDA219947

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84403	ORIG	2025-12-15
84219	ORIG	2025-11-19
84195	ORIG	2025-11-18