Application 076644

Type: ANDA
Sponsor: MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG	No	No
002	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	TABLET, EXTENDED RELEASE;ORAL	15MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076644-001	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL			2006-11-09
A076644-002	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL			2007-05-10

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076644-001	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2006-11-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076644-002	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076644-001	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2006-11-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076644-002	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076644-001	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2006-11-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076644-002	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076644-001	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2006-11-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076644-002	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076644-001	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2006-11-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076644-002	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076644-001	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2006-11-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076644-002	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076644-001	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2006-11-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076644-002	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076644-001	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2006-11-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076644-002	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076644-001	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2006-11-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076644-002	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076644-001	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2006-11-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076644-002	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076644-001	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2006-11-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076644-002	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076644-001	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2006-11-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076644-002	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076644-001	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2006-11-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076644-002	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076644-001	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2006-11-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076644-002	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076644-001	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2006-11-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076644-002	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076644-001	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2006-11-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076644-002	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076644-001	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2006-11-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076644-002	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076644-001	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2006-11-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076644-002	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076644-001	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2006-11-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076644-002	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076644-001	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-11-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076644-002	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-05-10	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076644-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076644-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A076644-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076644-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076644-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076644-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076644-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076644-002	AB	1	`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 2 of 4 · 78 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Northwind Health Company, LLC	13a79659-a181-6a61-e063-6294a90ae034	2025-12-26	Warnings, Adverse reactions	Name fallback brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Coupler LLC	3f7dc283-b168-8251-e063-6294a90a45a2	2025-12-24	Warnings, Adverse reactions	Name fallback brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Coupler LLC	3f7da2a3-ca46-d3e8-e063-6294a90abef3	2025-12-24	Warnings, Adverse reactions	Name fallback brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
oxybutynin chloride	OXYBUTYNIN CHLORIDE	Chartwell RX, LLC	e464c8dd-5222-4a6b-b7e9-ca608a403c6e	2025-12-22	Warnings, Adverse reactions	Name fallback brand name: oxybutynin chloride generic name: OXYBUTYNIN CHLORIDE
oxybutynin chloride	OXYBUTYNIN CHLORIDE	Accord Healthcare, Inc.	61496a1e-17bf-4f45-a20c-5bb98fe545ee	2025-12-16	Warnings, Adverse reactions	Name fallback brand name: oxybutynin chloride generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride Extended Release	OXYBUTYNIN CHLORIDE	AvKARE	94471401-a516-0fe7-ec9c-447dd2bee972	2025-12-16	Warnings, Adverse reactions	Name fallback generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Upsher-Smith Laboratories, LLC	3ee6835a-7a7d-49a9-8460-2f1dd270ead3	2025-12-11	Warnings, Adverse reactions	Name fallback brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Ajanta Pharma USA Inc.	95c2a144-ba0d-4011-ae0f-0e0ca876e8a8	2025-11-30	Warnings, Adverse reactions	Name fallback brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	A-S Medication Solutions	44990ed6-b8e7-40f5-b636-e848024ec6d8	2025-11-18	Warnings, Adverse reactions	Name fallback brand name: OXYBUTYNIN CHLORIDE generic name: OXYBUTYNIN CHLORIDE
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	A-S Medication Solutions	0697b3cf-b146-47c0-b5a5-5905ae8d1c97	2025-11-18	Warnings, Adverse reactions	Name fallback brand name: OXYBUTYNIN CHLORIDE generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	VERITYRX, LLC	427b6ffb-3ff4-932f-e063-6394a90ae8b9	2025-10-31	Warnings, Adverse reactions	Name fallback brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride Extended Release	OXYBUTYNIN CHLORIDE	PD-Rx Pharmaceuticals, Inc.	b5653b7e-1e3b-4da3-b3a2-33318f448c67	2025-10-20	Warnings, Adverse reactions	Name fallback generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride Extended Release	OXYBUTYNIN CHLORIDE	PD-Rx Pharmaceuticals, Inc.	e466d963-469a-4b1c-87f9-2e3e1e9bdf3d	2025-10-02	Warnings, Adverse reactions	Name fallback generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Major Pharmaceuticals	7769ad3d-6228-4b2d-8f44-4efe990d3fad	2025-09-19	Warnings, Adverse reactions	Name fallback brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Cardinal Health 107, LLC	8455b543-81ce-4522-ae9b-8396f944945c	2025-08-18	Warnings, Adverse reactions	Name fallback brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	PD-Rx Pharmaceuticals, Inc.	8bd5dce0-d56a-4e64-8de7-e7cd7775526b	2025-08-18	Warnings, Adverse reactions	Name fallback brand name: OXYBUTYNIN CHLORIDE generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Major Pharmaceuticals	7688cce8-797d-454c-95fb-52689741582e	2025-07-15	Warnings, Adverse reactions	Name fallback brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride Extended Release	OXYBUTYNIN CHLORIDE	Rising Pharma Holdings, Inc.	ab431781-3183-4638-b656-f40a61f07940	2025-05-19	Warnings, Adverse reactions	Name fallback generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	AvKARE	3418ca19-feb0-9821-e063-6394a90ae819	2025-05-01	Warnings, Adverse reactions	Name fallback brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride Extended Release	OXYBUTYNIN CHLORIDE	AvPAK	242b4766-bc2b-0073-d72d-1bf879bbee24	2025-04-17	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 · 13 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-6610	Oxybutynin Chloride	oxybutynin chloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6610	Oxybutynin Chloride	oxybutynin chloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6610	Oxybutynin Chloride	oxybutynin chloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6615	Oxybutynin Chloride	oxybutynin chloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6615	Oxybutynin Chloride	oxybutynin chloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-6615	Oxybutynin Chloride	oxybutynin chloride	Mylan Pharmaceuticals Inc.	ANDA	Current
0615-7520	Oxybutynin Chloride	oxybutynin chloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-7520	Oxybutynin Chloride	oxybutynin chloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
51079-723	Oxybutynin Chloride	oxybutynin chloride	Mylan Institutional Inc.	ANDA	Current
51079-723	Oxybutynin Chloride	oxybutynin chloride	Mylan Institutional Inc.	ANDA	Current
55154-6298	Oxybutynin Chloride	oxybutynin chloride	Cardinal Health	ANDA	Current
70518-0965	Oxybutynin Chloride	oxybutynin chloride	REMEDYREPACK INC.	ANDA	Current
70518-0965	Oxybutynin Chloride	oxybutynin chloride	REMEDYREPACK INC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
43093	ORIG	2013-08-09
31150	ORIG	2006-11-14