Application 202513

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GELNIQUE 3%	OXYBUTYNIN	GEL, METERED;TRANSDERMAL	3%	Yes	No

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
N202513-001	GELNIQUE 3%	OXYBUTYNIN	3%	GEL, METERED / TRANSDERMAL		RLD	2011-12-07

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	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N202513-001	GELNIQUE 3%	3%	GEL, METERED / TRANSDERMAL	RLD	2011-12-07	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202513-001	7198801	2022-06-25		Drug product	2012-04-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202513-001	7198801	2022-06-25		Drug product	2012-04-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202513-001	7198801	2022-06-25		Drug product	2012-04-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202513-001	7029694	2020-04-26	U-318	Drug product	2012-04-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202513-001	7179483	2020-04-26	U-318		2012-04-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202513-001	8241662	2020-04-26	U-318		2012-08-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202513-001	7198801	2022-06-25		Drug product	2012-04-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202513-001	7198801	2022-06-25		Drug product	2012-04-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202513-001	7198801	2022-06-25		Drug product	2012-04-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202513-001	7198801	2022-06-25		Drug product	2012-04-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202513-001	7198801	2022-06-25		Drug product	2012-04-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202513-001	7029694	2020-04-26	U-318	Drug product	2012-04-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202513-001	7179483	2020-04-26	U-318		2012-04-27	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202513-001	8241662	2020-04-26	U-318		2012-08-23	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202513-001	7198801	2022-06-25		Drug product	2012-04-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202513-001	7029694	2020-04-26	U-318	Drug product	2012-04-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N202513-001	7179483	2020-04-26	U-318		2012-04-27	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N202513-001	8241662	2020-04-26	U-318		2012-08-23	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N202513-001	7198801	2022-06-25		Drug product	2012-04-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202513-001	7029694	2020-04-26	U-318	Drug product	2012-04-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N202513-001	7179483	2020-04-26	U-318		2012-04-27	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N202513-001	8241662	2020-04-26	U-318		2012-08-23	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N202513-001	7198801	2022-06-25		Drug product	2012-04-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202513-001	7029694	2020-04-26	U-318	Drug product	2012-04-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N202513-001	7179483	2020-04-26	U-318		2012-04-27	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N202513-001	8241662	2020-04-26	U-318		2012-08-23	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N202513-001	7198801	2022-06-25		Drug product	2012-04-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202513-001	7029694	2020-04-26	U-318	Drug product	2012-04-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N202513-001	7179483	2020-04-26	U-318		2012-04-27	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N202513-001	8241662	2020-04-26	U-318		2012-08-23	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N202513-001	7198801	2022-06-25		Drug product	2012-04-27	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N202513-001	7198801	2022-06-25		Drug product	2012-04-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N202513-001	7198801	2022-06-25		Drug product	2012-04-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N202513-001	7198801	2022-06-25		Drug product	2012-04-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N202513-001	7198801	2022-06-25		Drug product	2012-04-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N202513-001	7198801	2022-06-25		Drug product	2012-04-27	`cb3db0bc1861…`

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
oxybutynin	OXYBUTYNIN	Zydus Lifesciences Limited	f405a774-bd91-4513-b7c7-c44f0596d988	2024-12-03		Name fallback generic name: OXYBUTYNIN
oxybutynin	OXYBUTYNIN	NCS HealthCare of KY, LLC dba Vangard Labs	ec4fd95f-16dc-4acf-b560-b67b7aaef08b	2024-09-13	Warnings, Adverse reactions	Name fallback generic name: OXYBUTYNIN
Oxytrol for Women	OXYBUTYNIN	Allergan, Inc.	8cdc5b4d-ff8d-4010-97d7-313422a0b868	2024-08-15	Warnings	Name fallback generic name: OXYBUTYNIN
oxybutynin	OXYBUTYNIN	NCS HealthCare of KY, LLC dba Vangard Labs	ed10f0c9-23d6-4ded-b17f-ed474632a965	2024-08-12	Warnings, Adverse reactions	Name fallback generic name: OXYBUTYNIN
OXYTROL	OXYBUTYNIN	Allergan, Inc.	20dee37f-1412-44ed-9e8b-f4379ce23eb0	2024-05-29	Warnings, Adverse reactions	Name fallback generic name: OXYBUTYNIN
oxybutynin	OXYBUTYNIN	Zydus Pharmaceuticals USA Inc.	c042bf06-79a3-4dc7-ae05-3ef3cfae9d44	2023-11-07	Warnings, Adverse reactions	Name fallback generic name: OXYBUTYNIN
oxybutynin	OXYBUTYNIN	A-S Medication Solutions	1f95920c-5dc2-44e4-b61d-b2c5e05390ba	2023-02-06	Warnings, Adverse reactions	Name fallback generic name: OXYBUTYNIN

Documents#

Document, Submission type, Date table
Document	Submission type	Date
19354	SUPPL	2015-07-13
10060	SUPPL	2015-07-13
40189	SUPPL	2013-01-11
32269	SUPPL	2013-01-11
44859	ORIG	2012-06-26
43405	ORIG	2012-06-26
10059	ORIG	2011-12-14
40188	ORIG	2011-12-13