Application 217388

Type: NDA
Sponsor: ASTRAZENECA AB

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	WAINUA (AUTOINJECTOR)	EPLONTERSEN SODIUM	SOLUTION;SUBCUTANEOUS	EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML)	Yes	Yes
002	WAINUA	EPLONTERSEN SODIUM	SOLUTION;SUBCUTANEOUS	EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N217388-001	WAINUA (AUTOINJECTOR)	EPLONTERSEN SODIUM	EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2023-12-21
N217388-002	WAINUA	EPLONTERSEN SODIUM	EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2026-04-15

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217388-001	8101743	2026-04-01		Drug substance, Drug product	2024-01-18
N217388-001	9127276	2034-05-01		Drug substance	2024-01-18
N217388-001	9181549	2034-05-01		Drug substance	2024-01-18
N217388-001	10683499	2034-08-25	U-2378	Drug substance, Drug product	2024-01-18
N217388-002	9127276	2034-05-01		Drug substance	2026-06-12
N217388-002	9181549	2034-05-01		Drug substance	2026-06-12
N217388-002	10683499	2034-08-25	U-2378	Drug substance, Drug product	2026-06-12

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N217388-001	NCE	2028-12-21
N217388-001	ODE-461	2030-12-21

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
2026-08-01 22:54:32	2026-06	N217388-001	WAINUA (AUTOINJECTOR)	EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2023-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217388-002	WAINUA	EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML)	SOLUTION / SUBCUTANEOUS		RLD, RS	2026-04-15	`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
2026-08-01 22:54:32	2026-06	N217388-001	8101743	2026-04-01		Drug substance, Drug product	2024-01-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217388-001	9127276	2034-05-01		Drug substance	2024-01-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217388-001	9181549	2034-05-01		Drug substance	2024-01-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217388-001	10683499	2034-08-25	U-2378	Drug substance, Drug product	2024-01-18	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217388-002	9127276	2034-05-01		Drug substance	2026-06-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217388-002	9181549	2034-05-01		Drug substance	2026-06-12	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217388-002	10683499	2034-08-25	U-2378	Drug substance, Drug product	2026-06-12	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-01 22:54:32	2026-06	N217388-001	NCE	2028-12-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217388-001	ODE-461	2030-12-21	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
WAINUA	EPLONTERSEN	AstraZeneca Pharmaceuticals LP	d7dcb847-71dd-4fff-82d0-d43a465fc096	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 217388 application number: NDA217388

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85712	SUPPL	2026-04-20
85697	SUPPL	2026-04-16
84465	SUPPL	2025-12-19
82104	SUPPL	2025-05-01
82030	SUPPL	2025-04-28
79745	SUPPL	2024-09-26
79742	SUPPL	2024-09-26
77197	ORIG	2024-01-09
77109	ORIG	2023-12-22
77100	ORIG	2023-12-21