Application 076745

Type: ANDA
Sponsor: IMPAX PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	TABLET, EXTENDED RELEASE;ORAL	15MG	No	No
002	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG	No	No
003	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	Approval date
A076745-001	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	2006-11-09
A076745-002	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	2007-05-09
A076745-003	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	2007-05-09

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 3 of 4 · 132 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
2020-11-12 02:37 UTC	2020-11	A076745-003	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076745-001	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-11-09	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076745-002	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-05-09	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076745-003	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-05-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076745-001	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-11-09	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076745-002	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-05-09	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076745-003	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-05-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076745-001	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2006-11-09	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076745-002	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-05-09	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076745-003	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2007-05-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076745-001	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL		2006-11-09	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076745-002	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-09	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076745-003	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076745-001	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL		2006-11-09	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A076745-002	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-09	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A076745-003	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076745-001	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL		2006-11-09	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A076745-002	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-09	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A076745-003	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076745-001	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL		2006-11-09	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076745-002	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-09	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076745-003	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076745-001	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL		2006-11-09	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076745-002	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-09	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076745-003	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076745-001	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL		2006-11-09	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076745-002	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-09	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076745-003	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076745-001	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL		2006-11-09	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076745-002	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-09	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076745-003	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076745-001	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL		2006-11-09	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A076745-002	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-09	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A076745-003	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076745-001	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL		2006-11-09	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A076745-002	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-09	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A076745-003	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076745-001	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL		2006-11-09	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076745-002	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-09	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076745-003	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL		2007-05-09	`3a93d1ddd44b…`

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	A076745-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076745-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076745-003	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A076745-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076745-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076745-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076745-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076745-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076745-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076745-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076745-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076745-003	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 1 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	REMEDYREPACK INC.	1a08a16a-f16d-4ef1-95bb-6943bcae0737	2026-07-28	Warnings, Adverse reactions	Name fallback brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	TruPharma LLC	7c497c6c-2448-2c80-e053-2991aa0ab8c7	2026-07-27	Warnings, Adverse reactions	Name fallback brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	RISING PHARMA HOLDINGS, INC.	9578b6b8-5b9d-4263-9142-39b2c7216b85	2026-07-21	Warnings, Adverse reactions	Name fallback brand name: OXYBUTYNIN CHLORIDE generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	ATLANTIC BIOLOGICALS CORP.	fe4ed76b-0009-455f-be30-47e80fc1afdf	2026-07-09	Warnings, Adverse reactions	Name fallback brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Coupler LLC	55f618d1-4463-3200-e063-6394a90a89a8	2026-07-06	Warnings, Adverse reactions	Name fallback brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Strides Pharma Science Limited	9ede5def-d185-4e40-9c10-8663ac654caf	2026-07-01	Warnings, Adverse reactions	Name fallback brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride Extended Release	OXYBUTYNIN CHLORIDE	American Health Packaging	0c71bdfb-01db-49ac-a8e9-0037df0d24af	2026-06-24	Warnings, Adverse reactions	Name fallback generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Strides Pharma Science Limited	ac10c7b7-d0cb-4068-93e2-c0e51f15866e	2026-06-01	Warnings, Adverse reactions	Name fallback brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	73d715dc-868d-4194-b668-4c39ababa698	2026-05-20	Warnings, Adverse reactions	Name fallback brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Bryant Ranch Prepack	a5965c8b-179d-4665-8a3b-324b693607ee	2026-05-19	Warnings, Adverse reactions	Name fallback brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
oxybutynin chloride	OXYBUTYNIN CHLORIDE	Bryant Ranch Prepack	7db4ab81-b379-4a6d-b469-95eb9e184b56	2026-05-14	Warnings, Adverse reactions	Name fallback brand name: oxybutynin chloride generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	American Health Packaging	4574b227-9726-4798-bac2-83bfb9616f09	2026-04-16	Warnings, Adverse reactions	Name fallback brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride Extended Release	OXYBUTYNIN CHLORIDE	A-S Medication Solutions	b9d0e5c8-3a71-40a0-a7d3-44bc043392fa	2026-02-17	Warnings, Adverse reactions	Name fallback generic name: OXYBUTYNIN CHLORIDE
oxybutynin chloride	OXYBUTYNIN CHLORIDE	PD-Rx Pharmaceuticals, Inc.	a1f8be75-2eb9-4eef-8fb4-144ef2bf7ae1	2026-02-16	Warnings, Adverse reactions	Name fallback brand name: oxybutynin chloride generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	9a551ec5-7e80-47c9-a7b9-f458c1478174	2026-02-16	Warnings, Adverse reactions	Name fallback brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Chartwell Governmental & Specialty RX, LLC.	46e78c72-a5a3-472f-9125-b120fa4eee31	2026-01-30	Adverse reactions	Name fallback brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Advagen Pharma Limited	7bd31561-4c76-4c6b-819b-492549886673	2026-01-14	Warnings, Adverse reactions	Name fallback brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride Extended Release	OXYBUTYNIN CHLORIDE	A-S Medication Solutions	3688227b-7655-40ca-b34b-073a39fd60f4	2026-01-14	Warnings, Adverse reactions	Name fallback generic name: OXYBUTYNIN CHLORIDE
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Northwind Health Company, LLC	f330b7a0-bbe0-0f00-e053-2a95a90a37b8	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Oxybutynin Chloride generic name: OXYBUTYNIN CHLORIDE
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

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 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-5206	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	TEVA Pharmaceuticals USA	ANDA	Current
0093-5206	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	TEVA Pharmaceuticals USA Inc	ANDA	Current
0093-5207	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	TEVA Pharmaceuticals USA	ANDA	Current
0093-5207	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	TEVA Pharmaceuticals USA Inc	ANDA	Current
0093-5208	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	TEVA Pharmaceuticals USA	ANDA	Current
0093-5208	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	TEVA Pharmaceuticals USA Inc	ANDA	Current
0179-0187	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	KAISER FOUNDATION HOSPITALS	ANDA	Current
63629-5484	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	Bryant Ranch Prepack	ANDA	Current
63629-6355	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	Bryant Ranch Prepack	ANDA	Current
66336-604	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	Dispensing Solutions, Inc.	ANDA	Current
68151-3646	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	Carilion Materials Management	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22583	ORIG	2013-08-09
8954	ORIG	2006-11-14