Application 020897

Type: NDA
Sponsor: JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DITROPAN XL	OXYBUTYNIN CHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG	Yes	No
002	DITROPAN XL	OXYBUTYNIN CHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG	Yes	No
003	DITROPAN XL	OXYBUTYNIN CHLORIDE	TABLET, EXTENDED RELEASE;ORAL	15MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N020897-001	DITROPAN XL	OXYBUTYNIN CHLORIDE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1998-12-16
N020897-002	DITROPAN XL	OXYBUTYNIN CHLORIDE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1998-12-16
N020897-003	DITROPAN XL	OXYBUTYNIN CHLORIDE	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1999-06-22

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020897-001	DITROPAN XL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1998-12-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020897-002	DITROPAN XL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1998-12-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020897-003	DITROPAN XL	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1999-06-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020897-001	DITROPAN XL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1998-12-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020897-002	DITROPAN XL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1998-12-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020897-003	DITROPAN XL	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1999-06-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020897-001	DITROPAN XL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1998-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020897-002	DITROPAN XL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1998-12-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020897-003	DITROPAN XL	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1999-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020897-001	DITROPAN XL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1998-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020897-002	DITROPAN XL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1998-12-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020897-003	DITROPAN XL	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1999-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020897-001	DITROPAN XL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1998-12-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020897-002	DITROPAN XL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1998-12-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020897-003	DITROPAN XL	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1999-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020897-001	DITROPAN XL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1998-12-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020897-002	DITROPAN XL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1998-12-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020897-003	DITROPAN XL	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1999-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020897-001	DITROPAN XL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1998-12-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020897-002	DITROPAN XL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1998-12-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020897-003	DITROPAN XL	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1999-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020897-001	DITROPAN XL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1998-12-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020897-002	DITROPAN XL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1998-12-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020897-003	DITROPAN XL	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1999-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020897-001	DITROPAN XL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1998-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020897-002	DITROPAN XL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1998-12-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020897-003	DITROPAN XL	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1999-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020897-001	DITROPAN XL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1998-12-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020897-002	DITROPAN XL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1998-12-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020897-003	DITROPAN XL	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1999-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020897-001	DITROPAN XL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1998-12-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020897-002	DITROPAN XL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1998-12-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020897-003	DITROPAN XL	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1999-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020897-001	DITROPAN XL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1998-12-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020897-002	DITROPAN XL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1998-12-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020897-003	DITROPAN XL	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1999-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020897-001	DITROPAN XL	5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1998-12-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020897-002	DITROPAN XL	10MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1998-12-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020897-003	DITROPAN XL	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1999-06-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020897-001	DITROPAN XL	5MG	TABLET, EXTENDED RELEASE / ORAL	RLD	1998-12-16	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020897-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020897-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020897-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020897-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020897-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020897-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020897-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020897-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020897-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020897-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020897-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020897-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020897-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020897-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020897-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020897-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020897-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020897-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020897-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020897-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020897-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020897-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020897-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020897-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020897-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020897-002	AB	1	`ea99ee380514…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020897-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020897-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020897-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020897-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020897-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020897-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020897-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020897-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020897-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020897-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020897-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N020897-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020897-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N020897-002	AB	1	`e64feba35796…`

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 3 of 4 · 77 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	PD-Rx Pharmaceuticals, Inc.	0c021aad-97a3-4404-a11e-cdd2ec731c6b	2025-03-07	Warnings, Adverse reactions	Name fallback generic name: OXYBUTYNIN CHLORIDE
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	PD-Rx Pharmaceuticals, Inc.	3a319017-4e25-402e-8ba0-63b9f1eb707e	2025-02-27	Warnings, Adverse reactions	Name fallback generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Chartwell RX, LLC	d02e411b-2f34-4d08-a92a-9762cab47269	2025-02-26	Adverse reactions	Name fallback generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Bryant Ranch Prepack	f92cf6d0-5f49-40e2-a4f4-8ff377cacbfb	2025-01-30	Warnings, Adverse reactions	Name fallback generic name: OXYBUTYNIN CHLORIDE
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	Redpharm Drug	fc4cfbe6-a940-41c0-e053-6294a90adb14	2025-01-23	Warnings, Adverse reactions	Name fallback generic name: OXYBUTYNIN CHLORIDE
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	direct rx	b3d6d2a8-97c4-5bad-e053-2a95a90a155d	2025-01-17	Warnings, Adverse reactions	Name fallback generic name: OXYBUTYNIN CHLORIDE
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	DIRECT RX	ada3be87-2cdd-75f7-e053-2995a90aa95b	2025-01-17	Warnings, Adverse reactions	Name fallback generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Golden State Medical Supply, Inc.	6f409d7f-b064-1363-e053-2a91aa0a3a14	2024-12-23	Warnings, Adverse reactions	Name fallback generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	KVK-Tech, Inc.	f99fdfe8-a980-4a72-bc99-aa2ce0bdfd86	2024-12-06	Warnings, Adverse reactions	Name fallback generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	ANI Pharmaceuticals, Inc.	3b1f5585-9b33-4a96-bf33-8e6bab14bf0c	2024-11-25	Warnings, Adverse reactions	Name fallback generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	2425f49f-ade3-5178-e063-6294a90adfac	2024-10-10	Warnings, Adverse reactions	Name fallback generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Bryant Ranch Prepack	246d2f79-8ab5-4023-9068-1451b695ac16	2024-10-03	Warnings, Adverse reactions	Name fallback generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Teva Pharmaceuticals USA, Inc.	cb7aba8d-6913-4f57-8eb4-c6d6ff0b2a29	2024-09-02	Warnings, Adverse reactions	Name fallback generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	NuCare Pharmaceuticals,Inc.	8e830697-a6d3-13ed-e053-2995a90acb11	2024-08-14	Warnings, Adverse reactions	Name fallback generic name: OXYBUTYNIN CHLORIDE
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	Bryant Ranch Prepack	f26e590d-956e-493b-a6ac-6056aeeaf411	2024-08-09	Warnings, Adverse reactions	Name fallback generic name: OXYBUTYNIN CHLORIDE
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	RISING PHARMA HOLDINGS, INC.	f8ed80f2-6c3d-4d7f-b761-c2447973c1f9	2024-07-03	Warnings, Adverse reactions	Name fallback generic name: OXYBUTYNIN CHLORIDE
oxybutynin chloride	OXYBUTYNIN CHLORIDE	A-S Medication Solutions	7593becc-250f-4d25-8401-a9f72f3f5ad4	2024-06-03	Warnings, Adverse reactions	Name fallback generic name: OXYBUTYNIN CHLORIDE
oxybutynin chloride	OXYBUTYNIN CHLORIDE	A-S Medication Solutions	8f147f73-cfc6-40a3-b1a3-e4cab1868523	2024-06-03	Warnings, Adverse reactions	Name fallback generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	A-S Medication Solutions	39a2d144-0c10-4aec-9fa4-0adc24b332eb	2024-06-03	Warnings, Adverse reactions	Name fallback generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride Extended Release	OXYBUTYNIN CHLORIDE	Bryant Ranch Prepack	169d6d58-8887-4bdd-95bd-873d1f049eaa	2024-05-24	Warnings, Adverse reactions	Name fallback generic name: OXYBUTYNIN CHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-7521	oxybutynin chloride	oxybutynin chloride	NCS HealthCare of KY, Inc dba Vangard Labs	NDA	Current
10147-0761	Oxybutynin Chloride	oxybutynin chloride	Patriot Pharmaceuticals, LLC	NDA	Current
10147-0761	Oxybutynin Chloride	oxybutynin chloride	Patriot Pharmaceuticals,	NDA	Current
10147-0761	Oxybutynin Chloride	oxybutynin chloride	Patriot Pharmaceuticals, LLC	NDA	Current
10147-0771	Oxybutynin Chloride	oxybutynin chloride	Patriot Pharmaceuticals, LLC	NDA	Current
10147-0771	Oxybutynin Chloride	oxybutynin chloride	Patriot Pharmaceuticals,	NDA	Current
10147-0771	Oxybutynin Chloride	oxybutynin chloride	Patriot Pharmaceuticals, LLC	NDA	Current
50458-805	Ditropan	oxybutynin chloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-805	Ditropan	oxybutynin chloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-805	Ditropan	oxybutynin chloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-805	Ditropan	oxybutynin chloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-805	Ditropan	oxybutynin chloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-805	Ditropan	oxybutynin chloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-805	Ditropan	oxybutynin chloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-810	Ditropan	oxybutynin chloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-810	Ditropan	oxybutynin chloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-810	Ditropan	oxybutynin chloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-810	Ditropan	oxybutynin chloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-810	Ditropan	oxybutynin chloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-810	Ditropan	oxybutynin chloride	Janssen Pharmaceuticals, Inc.	NDA	Current
50458-810	Ditropan	oxybutynin chloride	Janssen Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
66923	SUPPL	2021-03-30
66920	SUPPL	2021-03-30
59998	SUPPL	2019-09-13
59997	SUPPL	2019-09-13
56191	SUPPL	2018-11-06
56138	SUPPL	2018-10-29
45407	SUPPL	2016-09-28
45294	SUPPL	2016-09-15
35595	SUPPL	2015-03-04
3684	SUPPL	2015-03-02
35594	SUPPL	2013-08-09
26140	SUPPL	2013-08-05
13693	SUPPL	2012-11-15
26139	SUPPL	2012-11-14
35593	SUPPL	2012-03-27
3683	SUPPL	2012-03-27
35592	SUPPL	2011-12-20
26138	SUPPL	2011-12-20
3682	SUPPL	2011-07-05
13692	SUPPL	2011-06-30
13691	SUPPL	2009-07-23
26137	SUPPL	2009-07-17
3681	SUPPL	2008-03-17
13690	SUPPL	2008-02-14
41790	SUPPL	2007-04-11
35591	SUPPL	2004-07-01
26136	SUPPL	2004-06-30
3680	SUPPL	2003-05-29
35590	SUPPL	2003-04-16
13689	SUPPL	2003-04-16
35589	ORIG	1998-12-16
26135	ORIG	1998-12-16
21049	ORIG	1998-12-16
53120	ORIG	1900-01-01
53119	ORIG	1900-01-01
53118	ORIG	1900-01-01