Application 217424

Type: NDA
Sponsor: LNHC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZELSUVMI	BERDAZIMER SODIUM	GEL;TOPICAL	EQ 10.3% BASE	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
N217424-001	ZELSUVMI	BERDAZIMER SODIUM	EQ 10.3% BASE	GEL / TOPICAL		RLD, RS	2024-01-05

Orange Book patents#

Current patent rows page 1 of 1 · 22 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217424-001	8282967	2026-05-30		Drug substance	2024-02-02
N217424-001	8956658	2026-05-30		Drug substance	2024-02-02
N217424-001	10376538	2030-08-20		Drug product	2024-02-02
N217424-001	9737561	2030-08-20	U-3802		2024-02-02
N217424-001	9526738	2031-09-03		Drug product	2024-02-02
N217424-001	10265334	2032-07-03		Drug product	2024-02-02
N217424-001	9289442	2032-07-03	U-3803	Drug product	2024-02-02
N217424-001	9855211	2034-02-27	U-3800	Drug product	2024-02-02
N217424-001	9855211	2034-02-27	U-3801	Drug product	2024-02-02
N217424-001	11285098	2034-02-28		Drug product	2024-02-02
N217424-001	10258564	2034-11-22	U-3797		2024-02-02
N217424-001	10258564	2034-11-22	U-3798		2024-02-02
N217424-001	10258564	2034-11-22	U-3799		2024-02-02
N217424-001	10322081	2035-07-10	U-3793		2024-02-02
N217424-001	10322081	2035-07-10	U-3794		2024-02-02
N217424-001	10322081	2035-07-10	U-3795		2024-02-02
N217424-001	10322081	2035-07-10	U-3796		2024-02-02
N217424-001	10736839	2035-07-10	U-3790		2024-02-02
N217424-001	10736839	2035-07-10	U-3791		2024-02-02
N217424-001	10736839	2035-07-10	U-3792		2024-02-02
N217424-001	11040006	2035-07-10	U-3789	Drug product	2024-02-02
N217424-001	11723858	2035-07-10	U-3788	Drug product	2024-02-02

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N217424-001	NCE	2029-01-05

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	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217424-001	ZELSUVMI	EQ 10.3% BASE	GEL / TOPICAL	RLD, RS	2024-01-05	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 11 · 402 observed states.

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	N217424-001	8282967	2026-05-30		Drug substance	2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	8956658	2026-05-30		Drug substance	2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	10376538	2030-08-20		Drug product	2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	9737561	2030-08-20	U-3802		2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	9526738	2031-09-03		Drug product	2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	10265334	2032-07-03		Drug product	2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	9289442	2032-07-03	U-3803	Drug product	2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	9855211	2034-02-27	U-3800	Drug product	2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	9855211	2034-02-27	U-3801	Drug product	2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	11285098	2034-02-28		Drug product	2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	10258564	2034-11-22	U-3797		2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	10258564	2034-11-22	U-3798		2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	10258564	2034-11-22	U-3799		2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	10322081	2035-07-10	U-3793		2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	10322081	2035-07-10	U-3794		2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	10322081	2035-07-10	U-3795		2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	10322081	2035-07-10	U-3796		2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	10736839	2035-07-10	U-3790		2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	10736839	2035-07-10	U-3791		2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	10736839	2035-07-10	U-3792		2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	11040006	2035-07-10	U-3789	Drug product	2024-02-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217424-001	11723858	2035-07-10	U-3788	Drug product	2024-02-02	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217424-001	8282967	2026-05-30		Drug substance	2024-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217424-001	8956658	2026-05-30		Drug substance	2024-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217424-001	10376538	2030-08-20		Drug product	2024-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217424-001	9737561	2030-08-20	U-3802		2024-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217424-001	9526738	2031-09-03		Drug product	2024-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217424-001	10265334	2032-07-03		Drug product	2024-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217424-001	9289442	2032-07-03	U-3803	Drug product	2024-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217424-001	9855211	2034-02-27	U-3800	Drug product	2024-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217424-001	9855211	2034-02-27	U-3801	Drug product	2024-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217424-001	11285098	2034-02-28		Drug product	2024-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217424-001	10258564	2034-11-22	U-3797		2024-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217424-001	10258564	2034-11-22	U-3798		2024-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217424-001	10258564	2034-11-22	U-3799		2024-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217424-001	10322081	2035-07-10	U-3793		2024-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217424-001	10322081	2035-07-10	U-3794		2024-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217424-001	10322081	2035-07-10	U-3795		2024-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217424-001	10322081	2035-07-10	U-3796		2024-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217424-001	10736839	2035-07-10	U-3790		2024-02-02	`caaa826d4ba7…`

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	N217424-001	NCE	2029-01-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217424-001	NCE	2029-01-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217424-001	NCE	2029-01-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217424-001	NCE	2029-01-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217424-001	NCE	2029-01-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217424-001	NCE	2029-01-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217424-001	NCE	2029-01-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217424-001	NCE	2029-01-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217424-001	NCE	2029-01-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217424-001	NCE	2029-01-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217424-001	NCE	2029-01-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217424-001	NCE	2029-01-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217424-001	NCE	2029-01-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217424-001	NCE	2029-01-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217424-001	NCE	2029-01-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217424-001	NCE	2029-01-05	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217424-001	NCE	2029-01-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217424-001	NCE	2029-01-05	`1c564ffb4f44…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217424-001	NCE	2029-01-05	`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
ZELSUVMI	BERDAZIMER	LNHC, Inc.	76b17622-bdb9-41ea-b962-c2acc0df71f7	2025-07-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 217424 application number: NDA217424

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
77394	ORIG	2024-02-02
77241	ORIG	2024-01-19
77236	ORIG	2024-01-17