Application 215842

Type: NDA
Sponsor: NOVO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RIVFLOZA	NEDOSIRAN SODIUM	SOLUTION;INJECTION	EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)	Yes	Yes
002	RIVFLOZA	NEDOSIRAN SODIUM	SOLUTION;INJECTION	EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)	Yes	Yes
003	RIVFLOZA	NEDOSIRAN SODIUM	SOLUTION;INJECTION	EQ 160MG BASE/ML (EQ 160MG BASE/ML)	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N215842-001	RIVFLOZA	NEDOSIRAN SODIUM	EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29
N215842-002	RIVFLOZA	NEDOSIRAN SODIUM	EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29
N215842-003	RIVFLOZA	NEDOSIRAN SODIUM	EQ 160MG BASE/ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215842-001	10351854	2035-10-09		Drug substance, Drug product	2023-10-26
N215842-001	10738311	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26
N215842-001	11359203	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26
N215842-001	11053502	2035-10-29		Drug substance, Drug product	2023-10-26
N215842-001	11286488	2038-10-12	U-3709	Drug substance, Drug product	2023-10-26
N215842-001	11661604	2038-10-12	U-3709	Drug substance, Drug product	2023-10-26
N215842-002	10351854	2035-10-09		Drug substance, Drug product	2023-10-26
N215842-002	10738311	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26
N215842-002	11359203	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26
N215842-002	11053502	2035-10-29		Drug substance, Drug product	2023-10-26
N215842-002	11286488	2038-10-12	U-3709	Drug substance, Drug product	2023-10-26
N215842-002	11661604	2038-10-12	U-3709	Drug substance, Drug product	2023-10-26
N215842-003	10351854	2035-10-09		Drug substance, Drug product	2023-10-26
N215842-003	10738311	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26
N215842-003	11359203	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26
N215842-003	11053502	2035-10-29		Drug substance, Drug product	2023-10-26
N215842-003	11286488	2038-10-12	U-3709	Drug substance, Drug product	2023-10-26
N215842-003	11661604	2038-10-12	U-3709	Drug substance, Drug product	2023-10-26

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 12 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215842-001	NPP	2028-03-27
N215842-001	NCE	2028-09-29
N215842-001	ODE-443	2030-09-29
N215842-001	ODE-531	2032-03-27
N215842-002	NPP	2028-03-27
N215842-002	NCE	2028-09-29
N215842-002	ODE-443	2030-09-29
N215842-002	ODE-531	2032-03-27
N215842-003	NPP	2028-03-27
N215842-003	NCE	2028-09-29
N215842-003	ODE-443	2030-09-29
N215842-003	ODE-531	2032-03-27

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 · 63 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N215842-001	RIVFLOZA	EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-002	RIVFLOZA	EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-003	RIVFLOZA	EQ 160MG BASE/ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215842-001	RIVFLOZA	EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-002	RIVFLOZA	EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-003	RIVFLOZA	EQ 160MG BASE/ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215842-001	RIVFLOZA	EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215842-002	RIVFLOZA	EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215842-003	RIVFLOZA	EQ 160MG BASE/ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215842-001	RIVFLOZA	EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215842-002	RIVFLOZA	EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215842-003	RIVFLOZA	EQ 160MG BASE/ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215842-001	RIVFLOZA	EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215842-002	RIVFLOZA	EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215842-003	RIVFLOZA	EQ 160MG BASE/ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215842-001	RIVFLOZA	EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215842-002	RIVFLOZA	EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215842-003	RIVFLOZA	EQ 160MG BASE/ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215842-001	RIVFLOZA	EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215842-002	RIVFLOZA	EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215842-003	RIVFLOZA	EQ 160MG BASE/ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215842-001	RIVFLOZA	EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215842-002	RIVFLOZA	EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215842-003	RIVFLOZA	EQ 160MG BASE/ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215842-001	RIVFLOZA	EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215842-002	RIVFLOZA	EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215842-003	RIVFLOZA	EQ 160MG BASE/ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215842-001	RIVFLOZA	EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215842-002	RIVFLOZA	EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N215842-003	RIVFLOZA	EQ 160MG BASE/ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N215842-001	RIVFLOZA	EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215842-002	RIVFLOZA	EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N215842-003	RIVFLOZA	EQ 160MG BASE/ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215842-001	RIVFLOZA	EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215842-002	RIVFLOZA	EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N215842-003	RIVFLOZA	EQ 160MG BASE/ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215842-001	RIVFLOZA	EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215842-002	RIVFLOZA	EQ 128MG BASE/0.8ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N215842-003	RIVFLOZA	EQ 160MG BASE/ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N215842-001	RIVFLOZA	EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML)	SOLUTION / INJECTION	RLD, RS	2023-09-29	`1e350fbaab3a…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 360 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N215842-001	10351854	2035-10-09		Drug substance, Drug product	2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-001	10738311	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-001	11359203	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-001	11053502	2035-10-29		Drug substance, Drug product	2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-001	11286488	2038-10-12	U-3709	Drug substance, Drug product	2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-001	11661604	2038-10-12	U-3709	Drug substance, Drug product	2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-002	10351854	2035-10-09		Drug substance, Drug product	2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-002	10738311	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-002	11359203	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-002	11053502	2035-10-29		Drug substance, Drug product	2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-002	11286488	2038-10-12	U-3709	Drug substance, Drug product	2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-002	11661604	2038-10-12	U-3709	Drug substance, Drug product	2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-003	10351854	2035-10-09		Drug substance, Drug product	2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-003	10738311	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-003	11359203	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-003	11053502	2035-10-29		Drug substance, Drug product	2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-003	11286488	2038-10-12	U-3709	Drug substance, Drug product	2023-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-003	11661604	2038-10-12	U-3709	Drug substance, Drug product	2023-10-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215842-001	10351854	2035-10-09		Drug substance, Drug product	2023-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-001	10738311	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-001	11359203	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-001	11053502	2035-10-29		Drug substance, Drug product	2023-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-001	11286488	2038-10-12	U-3709	Drug substance, Drug product	2023-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-001	11661604	2038-10-12	U-3709	Drug substance, Drug product	2023-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-002	10351854	2035-10-09		Drug substance, Drug product	2023-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-002	10738311	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-002	11359203	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-002	11053502	2035-10-29		Drug substance, Drug product	2023-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-002	11286488	2038-10-12	U-3709	Drug substance, Drug product	2023-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-002	11661604	2038-10-12	U-3709	Drug substance, Drug product	2023-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-003	10351854	2035-10-09		Drug substance, Drug product	2023-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-003	10738311	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-003	11359203	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-003	11053502	2035-10-29		Drug substance, Drug product	2023-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-003	11286488	2038-10-12	U-3709	Drug substance, Drug product	2023-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-003	11661604	2038-10-12	U-3709	Drug substance, Drug product	2023-10-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215842-001	10351854	2035-10-09		Drug substance, Drug product	2023-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215842-001	10738311	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215842-001	11359203	2035-10-09	U-3709	Drug substance, Drug product	2023-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215842-001	11053502	2035-10-29		Drug substance, Drug product	2023-10-26	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 4 · 141 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N215842-001	NPP	2028-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-001	NCE	2028-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-001	ODE-443	2030-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-001	ODE-531	2032-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-002	NPP	2028-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-002	NCE	2028-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-002	ODE-443	2030-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-002	ODE-531	2032-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-003	NPP	2028-03-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-003	NCE	2028-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-003	ODE-443	2030-09-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N215842-003	ODE-531	2032-03-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N215842-001	NPP	2028-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-001	NCE	2028-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-001	ODE-443	2030-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-002	NPP	2028-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-002	NCE	2028-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-002	ODE-443	2030-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-003	NPP	2028-03-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-003	NCE	2028-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215842-003	ODE-443	2030-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215842-001	NPP	2028-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215842-001	NCE	2028-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215842-001	ODE-443	2030-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215842-002	NPP	2028-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215842-002	NCE	2028-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215842-002	ODE-443	2030-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215842-003	NPP	2028-03-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215842-003	NCE	2028-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215842-003	ODE-443	2030-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215842-001	NPP	2028-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215842-001	NCE	2028-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215842-001	ODE-443	2030-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215842-002	NPP	2028-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215842-002	NCE	2028-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215842-002	ODE-443	2030-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215842-003	NPP	2028-03-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215842-003	NCE	2028-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215842-003	ODE-443	2030-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215842-001	NCE	2028-09-29	`fd3edfee7708…`

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
RIVFLOZA	NEDOSIRAN	Novo Nordisk	ace9d4bc-4d20-4beb-9e9d-888690424833	2025-03-03	Adverse reactions	Exact identifier application applno (NDA): 215842 application number: NDA215842

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81775	SUPPL	2025-03-28
81772	SUPPL	2025-03-27
75841	ORIG	2023-10-19
75651	ORIG	2023-10-03
75631	ORIG	2023-09-29