Application 217347

Type: NDA
Sponsor: BOTANIX SB

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SOFDRA	SOFPIRONIUM BROMIDE	GEL, METERED;TOPICAL	EQ 12.45% BASE (EQ 72MG BASE/ACTUATION)	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
N217347-001	SOFDRA	SOFPIRONIUM BROMIDE	EQ 12.45% BASE (EQ 72MG BASE/ACTUATION)	GEL, METERED / TOPICAL		RLD, RS	2024-06-18

Orange Book patents#

Current patent rows page 1 of 1 · 21 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217347-001	8628759	2026-11-13	U-2398		2024-09-26
N217347-001	8147809	2027-03-26		Drug substance, Drug product	2024-09-26
N217347-001	10383846	2034-03-14	U-2398		2024-09-26
N217347-001	9220707	2034-03-14	U-2398		2024-09-26
N217347-001	9492429	2034-03-14	U-2398	Drug product	2024-09-26
N217347-001	9895350	2034-03-14	U-2398		2024-09-26
N217347-001	10947192	2034-05-22	U-2398		2024-09-26
N217347-001	10952990	2034-05-22	U-2398		2024-09-26
N217347-001	10959983	2034-05-22	U-2398		2024-09-26
N217347-001	10961191	2034-05-22	U-2398		2024-09-26
N217347-001	11026919	2034-05-22	U-2398	Drug product	2024-09-26
N217347-001	11034652	2034-05-22	U-2398	Drug product	2024-09-26
N217347-001	11052067	2034-05-22	U-2398	Drug product	2024-09-26
N217347-001	11084788	2034-05-22	U-2398	Drug product	2024-09-26
N217347-001	12156865	2034-05-22	U-2398	Drug product	2025-06-10
N217347-001	12357609	2034-05-22	U-2398	Drug product	2025-08-14
N217347-001	12398102	2034-05-22	U-2398	Drug product	2025-09-23
N217347-001	11123325	2037-07-20	U-2398	Drug product	2024-09-26
N217347-001	11566000	2040-05-22		Drug substance, Drug product	2024-09-26
N217347-001	11584715	2040-05-22		Drug substance, Drug product	2024-09-26
N217347-001	12703682	2040-05-22		Drug substance, Drug product	2026-09-08

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N217347-001	NCE	2029-06-20

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	N217347-001	SOFDRA	EQ 12.45% BASE (EQ 72MG BASE/ACTUATION)	GEL, METERED / TOPICAL	RLD, RS	2024-06-18	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217347-001	SOFDRA	EQ 12.45% BASE (EQ 72MG BASE/ACTUATION)	GEL, METERED / TOPICAL	RLD, RS	2024-06-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217347-001	SOFDRA	EQ 12.45% BASE (EQ 72MG BASE/ACTUATION)	GEL, METERED / TOPICAL	RLD, RS	2024-06-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217347-001	SOFDRA	EQ 12.45% BASE (EQ 72MG BASE/ACTUATION)	GEL, METERED / TOPICAL	RLD, RS	2024-06-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217347-001	SOFDRA	EQ 12.45% BASE (EQ 72MG BASE/ACTUATION)	GEL, METERED / TOPICAL	RLD, RS	2024-06-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217347-001	SOFDRA	EQ 12.45% BASE (EQ 72MG BASE/ACTUATION)	GEL, METERED / TOPICAL	RLD, RS	2024-06-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217347-001	SOFDRA	EQ 12.45% BASE (EQ 72MG BASE/ACTUATION)	GEL, METERED / TOPICAL	RLD, RS	2024-06-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217347-001	SOFDRA	EQ 12.45% BASE (EQ 72MG BASE/ACTUATION)	GEL, METERED / TOPICAL	RLD, RS	2024-06-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217347-001	SOFDRA	EQ 12.45% BASE (EQ 72MG BASE/ACTUATION)	GEL, METERED / TOPICAL	RLD, RS	2024-06-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217347-001	SOFDRA	EQ 12.45% BASE (EQ 72MG BASE/ACTUATION)	GEL, METERED / TOPICAL	RLD, RS	2024-06-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217347-001	SOFDRA	EQ 12.45% BASE (EQ 72MG BASE/ACTUATION)	GEL, METERED / TOPICAL	RLD, RS	2024-06-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217347-001	SOFDRA	EQ 12.45% BASE (EQ 72MG BASE/ACTUATION)	GEL, METERED / TOPICAL	RLD, RS	2024-06-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217347-001	SOFDRA	EQ 12.45% BASE (EQ 72MG BASE/ACTUATION)	GEL, METERED / TOPICAL	RLD, RS	2024-06-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217347-001	SOFDRA	EQ 12.45% BASE (EQ 72MG BASE/ACTUATION)	GEL, METERED / TOPICAL	RLD, RS	2024-06-18	`301d65b070ca…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217347-001	SOFDRA	EQ 12.45% BASE (EQ 72MG BASE/ACTUATION)	GEL, METERED / TOPICAL	RLD, RS	2024-06-18	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 207 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	N217347-001	8628759	2026-11-13	U-2398		2024-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217347-001	8147809	2027-03-26		Drug substance, Drug product	2024-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217347-001	10383846	2034-03-14	U-2398		2024-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217347-001	9220707	2034-03-14	U-2398		2024-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217347-001	9492429	2034-03-14	U-2398	Drug product	2024-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217347-001	9895350	2034-03-14	U-2398		2024-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217347-001	10947192	2034-05-22	U-2398		2024-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217347-001	10952990	2034-05-22	U-2398		2024-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217347-001	10959983	2034-05-22	U-2398		2024-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217347-001	10961191	2034-05-22	U-2398		2024-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217347-001	11026919	2034-05-22	U-2398	Drug product	2024-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217347-001	11034652	2034-05-22	U-2398	Drug product	2024-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217347-001	11052067	2034-05-22	U-2398	Drug product	2024-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217347-001	11084788	2034-05-22	U-2398	Drug product	2024-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217347-001	12156865	2034-05-22	U-2398	Drug product	2025-06-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217347-001	12357609	2034-05-22	U-2398	Drug product	2025-08-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217347-001	12398102	2034-05-22	U-2398	Drug product	2025-09-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217347-001	11123325	2037-07-20	U-2398	Drug product	2024-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217347-001	11566000	2040-05-22		Drug substance, Drug product	2024-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217347-001	11584715	2040-05-22		Drug substance, Drug product	2024-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217347-001	12703682	2040-05-22		Drug substance, Drug product	2026-09-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217347-001	8628759	2026-11-13	U-2398		2024-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217347-001	8147809	2027-03-26		Drug substance, Drug product	2024-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217347-001	10383846	2034-03-14	U-2398		2024-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217347-001	9220707	2034-03-14	U-2398		2024-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217347-001	9492429	2034-03-14	U-2398	Drug product	2024-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217347-001	9895350	2034-03-14	U-2398		2024-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217347-001	10947192	2034-05-22	U-2398		2024-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217347-001	10952990	2034-05-22	U-2398		2024-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217347-001	10959983	2034-05-22	U-2398		2024-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217347-001	10961191	2034-05-22	U-2398		2024-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217347-001	11026919	2034-05-22	U-2398	Drug product	2024-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217347-001	11034652	2034-05-22	U-2398	Drug product	2024-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217347-001	11052067	2034-05-22	U-2398	Drug product	2024-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217347-001	11084788	2034-05-22	U-2398	Drug product	2024-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217347-001	12156865	2034-05-22	U-2398	Drug product	2025-06-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217347-001	12357609	2034-05-22	U-2398	Drug product	2025-08-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217347-001	12398102	2034-05-22	U-2398	Drug product	2025-09-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217347-001	11123325	2037-07-20	U-2398	Drug product	2024-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217347-001	11566000	2040-05-22		Drug substance, Drug product	2024-09-26	`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	N217347-001	NCE	2029-06-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217347-001	NCE	2029-06-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217347-001	NCE	2029-06-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217347-001	NCE	2029-06-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217347-001	NCE	2029-06-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217347-001	NCE	2029-06-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217347-001	NCE	2029-06-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217347-001	NCE	2029-06-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217347-001	NCE	2029-06-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217347-001	NCE	2029-06-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217347-001	NCE	2029-06-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217347-001	NCE	2029-06-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217347-001	NCE	2029-06-20	`79d66fd596c7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217347-001	NCE	2029-06-20	`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
Sofdra	SOFPIRONIUM BROMIDE	Botanix SB Inc.	78f86f4f-658c-468b-bd54-49182ddcc7ac	2025-09-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 217347 application number: NDA217347

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
79108	ORIG	2024-07-17
78854	ORIG	2024-06-20
78844	ORIG	2024-06-20