Application 212905

Type: NDA
Sponsor: VERRICA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	YCANTH	CANTHARIDIN	SOLUTION;TOPICAL	0.7%	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
N212905-001	YCANTH	CANTHARIDIN	0.7%	SOLUTION / TOPICAL		RLD, RS	2023-07-21

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212905-001	11052064	2035-05-28	U-3663	Drug product	2023-08-15
N212905-001	11052064	2035-05-28	U-3665	Drug product	2023-08-15
N212905-001	11147790	2038-08-22	U-3663	Drug product	2023-08-15
N212905-001	11147790	2038-08-22	U-3664	Drug product	2023-08-15
N212905-001	12233042	2038-08-22	U-3663	Drug product	2025-03-26
N212905-001	12290651	2041-02-19		Drug product	2025-05-16

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N212905-001	NCE	2028-07-21

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N212905-001	YCANTH	0.7%	SOLUTION / TOPICAL	RLD, RS	2023-07-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N212905-001	YCANTH	0.7%	SOLUTION / TOPICAL	RLD, RS	2023-07-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212905-001	YCANTH	0.7%	SOLUTION / TOPICAL	RLD, RS	2023-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212905-001	YCANTH	0.7%	SOLUTION / TOPICAL	RLD, RS	2023-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212905-001	YCANTH	0.7%	SOLUTION / TOPICAL	RLD, RS	2023-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212905-001	YCANTH	0.7%	SOLUTION / TOPICAL	RLD, RS	2023-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212905-001	YCANTH	0.7%	SOLUTION / TOPICAL	RLD, RS	2023-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212905-001	YCANTH	0.7%	SOLUTION / TOPICAL	RLD, RS	2023-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212905-001	YCANTH	0.7%	SOLUTION / TOPICAL	RLD, RS	2023-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212905-001	YCANTH	0.7%	SOLUTION / TOPICAL	RLD, RS	2023-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212905-001	YCANTH	0.7%	SOLUTION / TOPICAL	RLD, RS	2023-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212905-001	YCANTH	0.7%	SOLUTION / TOPICAL	RLD, RS	2023-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212905-001	YCANTH	0.7%	SOLUTION / TOPICAL	RLD, RS	2023-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212905-001	YCANTH	0.7%	SOLUTION / TOPICAL	RLD, RS	2023-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212905-001	YCANTH	0.7%	SOLUTION / TOPICAL	RLD, RS	2023-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212905-001	YCANTH	0.7%	SOLUTION / TOPICAL	RLD, RS	2023-07-21	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N212905-001	YCANTH	0.7%	SOLUTION / TOPICAL	RLD, RS	2023-07-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N212905-001	YCANTH	0.7%	SOLUTION / TOPICAL	RLD, RS	2023-07-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N212905-001	YCANTH	0.7%	SOLUTION / TOPICAL	RLD, RS	2023-07-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N212905-001	YCANTH	0.7%	SOLUTION / TOPICAL	RLD, RS	2023-07-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N212905-001	YCANTH	0.7%	SOLUTION / TOPICAL	RLD, RS	2023-07-21	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212905-001	YCANTH	0.7%	SOLUTION / TOPICAL	RLD, RS	2023-07-21	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 100 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	N212905-001	11052064	2035-05-28	U-3665	Drug product	2023-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212905-001	11052064	2035-05-28	U-3663	Drug product	2023-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212905-001	11147790	2038-08-22	U-3663	Drug product	2023-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212905-001	11147790	2038-08-22	U-3664	Drug product	2023-08-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212905-001	12233042	2038-08-22	U-3663	Drug product	2025-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212905-001	12290651	2041-02-19		Drug product	2025-05-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N212905-001	11052064	2035-05-28	U-3665	Drug product	2023-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212905-001	11052064	2035-05-28	U-3663	Drug product	2023-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212905-001	11147790	2038-08-22	U-3663	Drug product	2023-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212905-001	11147790	2038-08-22	U-3664	Drug product	2023-08-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212905-001	12233042	2038-08-22	U-3663	Drug product	2025-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212905-001	12290651	2041-02-19		Drug product	2025-05-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212905-001	11052064	2035-05-28	U-3665	Drug product	2023-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212905-001	11052064	2035-05-28	U-3663	Drug product	2023-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212905-001	11147790	2038-08-22	U-3663	Drug product	2023-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212905-001	11147790	2038-08-22	U-3664	Drug product	2023-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212905-001	12233042	2038-08-22	U-3663	Drug product	2025-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212905-001	12290651	2041-02-19		Drug product	2025-05-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212905-001	11052064	2035-05-28	U-3665	Drug product	2023-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212905-001	11052064	2035-05-28	U-3663	Drug product	2023-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212905-001	11147790	2038-08-22	U-3663	Drug product	2023-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212905-001	11147790	2038-08-22	U-3664	Drug product	2023-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212905-001	12233042	2038-08-22	U-3663	Drug product	2025-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212905-001	12290651	2041-02-19		Drug product	2025-05-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212905-001	11052064	2035-05-28	U-3665	Drug product	2023-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212905-001	11052064	2035-05-28	U-3663	Drug product	2023-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212905-001	11147790	2038-08-22	U-3663	Drug product	2023-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212905-001	11147790	2038-08-22	U-3664	Drug product	2023-08-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212905-001	12233042	2038-08-22	U-3663	Drug product	2025-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212905-001	12290651	2041-02-19		Drug product	2025-05-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212905-001	11052064	2035-05-28	U-3665	Drug product	2023-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212905-001	11052064	2035-05-28	U-3663	Drug product	2023-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212905-001	11147790	2038-08-22	U-3663	Drug product	2023-08-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212905-001	11147790	2038-08-22	U-3664	Drug product	2023-08-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212905-001	11052064	2035-05-28	U-3665	Drug product	2023-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212905-001	11052064	2035-05-28	U-3663	Drug product	2023-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212905-001	11147790	2038-08-22	U-3663	Drug product	2023-08-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212905-001	11147790	2038-08-22	U-3664	Drug product	2023-08-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212905-001	11052064	2035-05-28	U-3665	Drug product	2023-08-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212905-001	11052064	2035-05-28	U-3663	Drug product	2023-08-15	`03ed91905a0d…`

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	N212905-001	NCE	2028-07-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N212905-001	NCE	2028-07-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212905-001	NCE	2028-07-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212905-001	NCE	2028-07-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212905-001	NCE	2028-07-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212905-001	NCE	2028-07-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212905-001	NCE	2028-07-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212905-001	NCE	2028-07-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212905-001	NCE	2028-07-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212905-001	NCE	2028-07-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212905-001	NCE	2028-07-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212905-001	NCE	2028-07-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212905-001	NCE	2028-07-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212905-001	NCE	2028-07-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N212905-001	NCE	2028-07-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N212905-001	NCE	2028-07-21	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N212905-001	NCE	2028-07-21	`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
YCANTH	CANTHARIDIN	Verrica Pharmaceuticals Inc.	7c9bdeaa-9822-4c69-a719-ea4a8643f59c	2024-11-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212905 application number: NDA212905

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
77247	ORIG	2024-01-22
74869	ORIG	2023-07-24
74867	ORIG	2023-07-21