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 4 of 4 · 78 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Oxybutynin Chloride Extended Release	OXYBUTYNIN CHLORIDE	Proficient Rx LP	7d2332b4-9e48-4bb2-a2c3-75e16e1d455b	2024-04-01	Warnings, Adverse reactions	Name fallback generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride Extended Release	OXYBUTYNIN CHLORIDE	Bryant Ranch Prepack	2f898b29-46cf-4427-bb64-8c30532222f5	2024-01-18	Warnings, Adverse reactions	Name fallback generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	A-S Medication Solutions	5e3b454b-6d3c-418b-8ac2-b0e17f018bbf	2023-12-27	Warnings, Adverse reactions	Name fallback brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	A-S Medication Solutions	afc6a3aa-e43d-4f10-bdbd-570a149bf9db	2023-12-27	Warnings, Adverse reactions	Name fallback brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	A-S Medication Solutions	83522acd-0ecc-46ac-a018-a3205ba096ff	2023-11-01	Warnings, Adverse reactions	Name fallback brand name: OXYBUTYNIN CHLORIDE generic name: OXYBUTYNIN CHLORIDE
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	5b72d34e-ae57-4459-ba2c-3bae8a69c5c1	2023-10-04	Warnings, Adverse reactions	Name fallback brand name: OXYBUTYNIN CHLORIDE generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride Extended Release	OXYBUTYNIN CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	02ff3be7-fc5c-4b91-8c67-ecdf6e19c42a	2023-05-31	Warnings, Adverse reactions	Name fallback generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	d2bb6927-5fbf-49ca-a891-d701bff1c812	2023-05-31	Warnings, Adverse reactions	Name fallback brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride Extended Release	OXYBUTYNIN CHLORIDE	Lannett Company, Inc.	c5950dba-d92b-46a0-993f-af9f9ddb52bf	2023-05-30	Warnings, Adverse reactions	Name fallback generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Amneal Pharmaceuticals LLC	53924eba-1919-4203-9a1e-d57dfdd3b963	2023-02-02	Warnings, Adverse reactions	Name fallback brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	1e1c1043-e4c5-4a06-9cc1-45d4397746f4	2023-01-04	Warnings, Adverse reactions	Name fallback brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Proficient Rx LP	e3f0c249-8085-4979-823a-820e233a284f	2022-06-01	Warnings, Adverse reactions	Name fallback brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
oxybutynin chloride	OXYBUTYNIN CHLORIDE	Proficient Rx LP	88f08450-559e-4038-aad1-051e4ab283cf	2022-06-01	Warnings, Adverse reactions	Name fallback brand name: oxybutynin chloride generic name: OXYBUTYNIN CHLORIDE
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	Leading Pharma, LLC	b73b8338-8045-448f-87a6-3d289227d00e	2022-02-14	Warnings, Adverse reactions	Name fallback brand name: OXYBUTYNIN CHLORIDE generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Lannett Company, Inc.	615f3d95-197c-4fec-b81f-c26449c93c3b	2020-02-21	Warnings, Adverse reactions	Name fallback brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride Extended Release	OXYBUTYNIN CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	e985e201-2fb3-4781-9790-a1a3db1ae2a1	2017-10-20	Warnings, Adverse reactions	Name fallback generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	58136f28-70c1-4cf2-bcd7-858c5609431a	2016-06-15	Warnings, Adverse reactions	Name fallback brand name: Oxybutynin Chloride 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