Application 211062

Type: ANDA
Sponsor: ATHEM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	TABLET;ORAL	5MG	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211062-001	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL			2019-02-06

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 2 · 43 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	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2019-02-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2019-02-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2019-02-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2019-02-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2019-02-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2019-02-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2019-02-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2019-02-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2019-02-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2019-02-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2019-02-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2019-02-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2019-02-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2019-02-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2019-02-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2019-02-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	BX	2019-02-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	BX	2019-02-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	BX	2019-02-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2019-02-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	BX	2019-02-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	BX	2019-02-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2019-02-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2019-02-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2019-02-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2019-02-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2019-02-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2019-02-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2019-02-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	BX	2019-02-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	BX	2019-02-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	BX	2019-02-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	BX	2019-02-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	BX	2019-02-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	BX	2019-02-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	BX	2019-02-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	BX	2019-02-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	BX	2019-02-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	BX	2019-02-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211062-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	BX	2019-02-06	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

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	A211062-001	BX	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211062-001	BX	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211062-001	BX	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211062-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211062-001	BX	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211062-001	BX	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211062-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211062-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211062-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211062-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211062-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211062-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211062-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211062-001	BX	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211062-001	BX	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211062-001	BX	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211062-001	BX	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211062-001	BX	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211062-001	BX	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211062-001	BX	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211062-001	BX	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211062-001	BX	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211062-001	BX	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211062-001	BX	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211062-001	BX	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211062-001	BX	1	`cb3db0bc1861…`

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 · 78 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	Preferred Pharmaceuticals Inc.	0e002fe8-fa3f-4a7d-84df-0c6e031e6ae4	2026-01-15	Warnings, 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

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 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68788-7785	Oxybutynin Chloride	Oxybutynin Chloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7785	Oxybutynin Chloride	Oxybutynin Chloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7785	Oxybutynin Chloride	Oxybutynin Chloride	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-2688	Oxybutynin Chloride	Oxybutynin Chloride	REMEDYREPACK INC.	ANDA	Current
70518-2688	Oxybutynin Chloride	Oxybutynin Chloride	REMEDYREPACK INC.	ANDA	Current
70518-2688	Oxybutynin Chloride	Oxybutynin Chloride	REMEDYREPACK INC.	ANDA	Current
71930-051	Oxybutynin Chloride	Oxybutynin Chloride	Eywa Pharma Inc	ANDA	Current