Application 210361

Type: NDA
Sponsor: DERMIRA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	QBREXZA	GLYCOPYRRONIUM TOSYLATE	CLOTH;TOPICAL	EQ 2.4% BASE	Yes	Yes

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

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
N210361-001	QBREXZA	GLYCOPYRRONIUM TOSYLATE	EQ 2.4% BASE	CLOTH / TOPICAL		RLD, RS	2018-06-28

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210361-001	10052267	2028-10-17	U-2398	Drug product	2018-09-20
N210361-001	8618160	2029-12-10	U-2398	Drug product	2018-09-20
N210361-001	9744105	2030-07-18	U-2398	Drug product	2018-09-20
N210361-001	10004717	2033-02-28	U-2398	Drug product	2018-09-20
N210361-001	10543192	2033-02-28		Drug product	2020-02-27
N210361-001	10548875	2033-02-28	U-2398	Drug substance, Drug product	2020-03-03
N210361-001	8859610	2033-02-28	U-2398	Drug product	2018-09-20
N210361-001	9259414	2033-02-28	U-2398		2018-09-20

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.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N210361-001	QBREXZA	EQ 2.4% BASE	CLOTH / TOPICAL	RLD, RS	2018-06-28	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 326 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210361-001	10052267	2028-10-17	U-2398	Drug product	2018-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210361-001	8618160	2029-12-10	U-2398	Drug product	2018-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210361-001	9744105	2030-07-18	U-2398	Drug product	2018-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210361-001	10004717	2033-02-28	U-2398	Drug product	2018-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210361-001	10543192	2033-02-28		Drug product	2020-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210361-001	10548875	2033-02-28	U-2398	Drug substance, Drug product	2020-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210361-001	8859610	2033-02-28	U-2398	Drug product	2018-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210361-001	9259414	2033-02-28	U-2398		2018-09-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210361-001	10052267	2028-10-17	U-2398	Drug product	2018-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210361-001	8618160	2029-12-10	U-2398	Drug product	2018-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210361-001	9744105	2030-07-18	U-2398	Drug product	2018-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210361-001	10004717	2033-02-28	U-2398	Drug product	2018-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210361-001	10543192	2033-02-28		Drug product	2020-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210361-001	10548875	2033-02-28	U-2398	Drug substance, Drug product	2020-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210361-001	8859610	2033-02-28	U-2398	Drug product	2018-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210361-001	9259414	2033-02-28	U-2398		2018-09-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210361-001	10052267	2028-10-17	U-2398	Drug product	2018-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210361-001	8618160	2029-12-10	U-2398	Drug product	2018-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210361-001	9744105	2030-07-18	U-2398	Drug product	2018-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210361-001	10004717	2033-02-28	U-2398	Drug product	2018-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210361-001	10543192	2033-02-28		Drug product	2020-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210361-001	10548875	2033-02-28	U-2398	Drug substance, Drug product	2020-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210361-001	8859610	2033-02-28	U-2398	Drug product	2018-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210361-001	9259414	2033-02-28	U-2398		2018-09-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210361-001	10052267	2028-10-17	U-2398	Drug product	2018-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210361-001	8618160	2029-12-10	U-2398	Drug product	2018-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210361-001	9744105	2030-07-18	U-2398	Drug product	2018-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210361-001	10004717	2033-02-28	U-2398	Drug product	2018-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210361-001	10543192	2033-02-28		Drug product	2020-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210361-001	10548875	2033-02-28	U-2398	Drug substance, Drug product	2020-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210361-001	8859610	2033-02-28	U-2398	Drug product	2018-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210361-001	9259414	2033-02-28	U-2398		2018-09-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210361-001	10052267	2028-10-17	U-2398	Drug product	2018-09-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210361-001	8618160	2029-12-10	U-2398	Drug product	2018-09-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210361-001	9744105	2030-07-18	U-2398	Drug product	2018-09-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210361-001	10004717	2033-02-28	U-2398	Drug product	2018-09-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210361-001	10543192	2033-02-28		Drug product	2020-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210361-001	10548875	2033-02-28	U-2398	Drug substance, Drug product	2020-03-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210361-001	8859610	2033-02-28	U-2398	Drug product	2018-09-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210361-001	9259414	2033-02-28	U-2398		2018-09-20	`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2021-12-28 21:50 UTC	2021-12	N210361-001	NP	2021-06-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210361-001	NP	2021-06-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210361-001	NP	2021-06-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210361-001	NP	2021-06-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210361-001	NP	2021-06-28	`c0c555d07b60…`

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
Qbrexza	GLYCOPYRRONIUM	Journey Medical Corporation	5b372650-e56e-47a5-93e2-c0c292017059	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210361 application number: NDA210361 ndc (product): 69489-411

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69489-411	Qbrexza	glycopyrronium	Journey Medical Corporation	NDA	Current
69489-411	Qbrexza	glycopyrronium	Journey Medical Corporation	NDA	Current
69489-411	Qbrexza	glycopyrronium	Journey Medical Corporation	NDA	Current
70428-011	Qbrexza	glycopyrronium	Dermira, Inc.	NDA	Current
70428-011	Qbrexza	glycopyrronium	Dermira, Inc.	NDA	Current
70428-011	Qbrexza	glycopyrronium	Journey Medical Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72525	SUPPL	2022-11-01
72504	SUPPL	2022-10-31
70694	SUPPL	2022-04-05
70680	SUPPL	2022-04-04
56528	ORIG	2018-11-20
54958	ORIG	2018-07-24
54748	ORIG	2018-07-05
63064	ORIG	1900-01-01