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 3 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	PD-Rx Pharmaceuticals, Inc.	9c8ced4b-94de-4df8-bea3-b42b8846b769	2025-03-12	Warnings, Adverse reactions	Name fallback brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	PD-Rx Pharmaceuticals, Inc.	0c021aad-97a3-4404-a11e-cdd2ec731c6b	2025-03-07	Warnings, Adverse reactions	Name fallback brand name: Oxybutynin Chloride 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 brand name: OXYBUTYNIN CHLORIDE generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Chartwell RX, LLC	d02e411b-2f34-4d08-a92a-9762cab47269	2025-02-26	Adverse reactions	Name fallback brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Bryant Ranch Prepack	f92cf6d0-5f49-40e2-a4f4-8ff377cacbfb	2025-01-30	Warnings, Adverse reactions	Name fallback brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	Redpharm Drug	fc4cfbe6-a940-41c0-e053-6294a90adb14	2025-01-23	Warnings, Adverse reactions	Name fallback brand name: OXYBUTYNIN CHLORIDE generic name: OXYBUTYNIN CHLORIDE
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	direct rx	b3d6d2a8-97c4-5bad-e053-2a95a90a155d	2025-01-17	Warnings, Adverse reactions	Name fallback brand name: OXYBUTYNIN CHLORIDE generic name: OXYBUTYNIN CHLORIDE
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	DIRECT RX	ada3be87-2cdd-75f7-e053-2995a90aa95b	2025-01-17	Warnings, Adverse reactions	Name fallback brand name: OXYBUTYNIN CHLORIDE 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 brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	KVK-Tech, Inc.	f99fdfe8-a980-4a72-bc99-aa2ce0bdfd86	2024-12-06	Warnings, Adverse reactions	Name fallback brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	ANI Pharmaceuticals, Inc.	3b1f5585-9b33-4a96-bf33-8e6bab14bf0c	2024-11-25	Warnings, Adverse reactions	Name fallback brand name: Oxybutynin Chloride 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 brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Bryant Ranch Prepack	246d2f79-8ab5-4023-9068-1451b695ac16	2024-10-03	Warnings, Adverse reactions	Name fallback brand name: Oxybutynin Chloride 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 brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	NuCare Pharmaceuticals,Inc.	8e830697-a6d3-13ed-e053-2995a90acb11	2024-08-14	Warnings, Adverse reactions	Name fallback brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	Bryant Ranch Prepack	f26e590d-956e-493b-a6ac-6056aeeaf411	2024-08-09	Warnings, Adverse reactions	Name fallback brand name: OXYBUTYNIN CHLORIDE 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 brand name: OXYBUTYNIN CHLORIDE 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 brand name: oxybutynin chloride 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 brand name: oxybutynin chloride 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 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