Application 202211

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXYTROL FOR WOMEN	OXYBUTYNIN	FILM, EXTENDED RELEASE;TRANSDERMAL	3.9MG/24HR	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
N202211-001	OXYTROL FOR WOMEN	OXYBUTYNIN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL		RLD, RS	2013-01-25

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	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N202211-001	OXYTROL FOR WOMEN	3.9MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	RLD, RS	2013-01-25	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N202211-001	6743441	2020-04-26	U-1329	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202211-001	7081249	2020-04-26	U-1329	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202211-001	7081250	2020-04-26	U-1329	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202211-001	7081251	2020-04-26	U-1329	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202211-001	7081252	2020-04-26	U-1329	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N202211-001	7179483	2020-04-26	U-1329		`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N202211-001	6743441	2020-04-26	U-1329	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202211-001	7081249	2020-04-26	U-1329	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202211-001	7081250	2020-04-26	U-1329	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202211-001	7081251	2020-04-26	U-1329	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202211-001	7081252	2020-04-26	U-1329	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N202211-001	7179483	2020-04-26	U-1329		`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N202211-001	6743441	2020-04-26	U-1329	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N202211-001	7081249	2020-04-26	U-1329	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N202211-001	7081250	2020-04-26	U-1329	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N202211-001	7081251	2020-04-26	U-1329	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N202211-001	7081252	2020-04-26	U-1329	Drug product	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N202211-001	7179483	2020-04-26	U-1329		`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N202211-001	6743441	2020-04-26	U-1329	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N202211-001	7081249	2020-04-26	U-1329	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N202211-001	7081250	2020-04-26	U-1329	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N202211-001	7081251	2020-04-26	U-1329	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N202211-001	7081252	2020-04-26	U-1329	Drug product	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N202211-001	7179483	2020-04-26	U-1329		`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N202211-001	6743441	2020-04-26	U-1329	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N202211-001	7081249	2020-04-26	U-1329	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N202211-001	7081250	2020-04-26	U-1329	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N202211-001	7081251	2020-04-26	U-1329	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N202211-001	7081252	2020-04-26	U-1329	Drug product	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N202211-001	7179483	2020-04-26	U-1329		`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N202211-001	6743441	2020-04-26	U-1329	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N202211-001	7081249	2020-04-26	U-1329	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N202211-001	7081250	2020-04-26	U-1329	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N202211-001	7081251	2020-04-26	U-1329	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N202211-001	7081252	2020-04-26	U-1329	Drug product	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N202211-001	7179483	2020-04-26	U-1329		`ea99ee380514…`

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
Oxytrol for Women	OXYBUTYNIN	Allergan, Inc.	8cdc5b4d-ff8d-4010-97d7-313422a0b868	2024-08-15	Warnings	Exact identifier application applno (NDA): 202211 application number: NDA202211 ndc (product): 0023-9637

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0023-9637	Oxytrol for Women	Oxybutynin	Allergan, Inc.	NDA	Current
0023-9637	Oxytrol for Women	Oxybutynin	Allergan, Inc.	NDA	Current
0023-9637	Oxytrol for Women	Oxybutynin	Allergan, Inc.	NDA	Current
0023-9637	Oxytrol for Women	Oxybutynin	Allergan, Inc.	NDA	Current
52544-166	Oxytrol For Women	oxybutynin	Actavis Pharma, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
40139	SUPPL	2016-03-04
32206	SUPPL	2016-03-04
19296	ORIG	2013-11-12
24410	ORIG	2013-11-05
22878	ORIG	2013-11-05
32205	ORIG	2013-01-30