Application 209335

Type: ANDA
Sponsor: ABHAI LLC

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 42.

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
A209335-001	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A209335-001	AB

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 · 42 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
2026-08-18 06:07:40	2026-07	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209335-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2017-12-22	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A209335-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209335-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209335-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209335-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209335-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209335-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209335-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209335-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209335-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209335-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209335-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209335-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209335-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209335-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209335-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209335-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209335-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209335-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209335-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209335-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209335-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209335-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209335-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209335-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209335-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209335-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209335-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209335-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209335-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209335-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209335-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209335-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209335-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209335-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209335-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209335-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209335-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209335-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209335-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209335-001	AB	1	`e64feba35796…`

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 1 · 8 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	Exact identifier application applno (ANDA): 209335 application number: ANDA209335 ndc (product): 70518-2640
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Preferred Pharmaceuticals Inc.	0e002fe8-fa3f-4a7d-84df-0c6e031e6ae4	2026-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209335 application number: ANDA209335 ndc (product): 68788-8141
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Northwind Health Company, LLC	13a79659-a181-6a61-e063-6294a90ae034	2025-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209335 application number: ANDA209335
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	PD-Rx Pharmaceuticals, Inc.	9c8ced4b-94de-4df8-bea3-b42b8846b769	2025-03-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209335 application number: ANDA209335 ndc (product): 43063-931
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	PD-Rx Pharmaceuticals, Inc.	0c021aad-97a3-4404-a11e-cdd2ec731c6b	2025-03-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209335 application number: ANDA209335 ndc (product): 43063-851
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Bryant Ranch Prepack	f92cf6d0-5f49-40e2-a4f4-8ff377cacbfb	2025-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209335 application number: ANDA209335 ndc (product): 71335-1494
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	KVK-Tech, Inc.	f99fdfe8-a980-4a72-bc99-aa2ce0bdfd86	2024-12-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209335 application number: ANDA209335 ndc (product): 10702-201
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	A-S Medication Solutions	39a2d144-0c10-4aec-9fa4-0adc24b332eb	2024-06-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209335 application number: ANDA209335 ndc (product): 50090-4622

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
10702-201	Oxybutynin Chloride	Oxybutynin Chloride	KVK-Tech, Inc.	ANDA	Current
10702-201	Oxybutynin Chloride	Oxybutynin Chloride	KVK-Tech, Inc.	ANDA	Current
43063-851	Oxybutynin Chloride	Oxybutynin Chloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-851	Oxybutynin Chloride	Oxybutynin Chloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-851	Oxybutynin Chloride	Oxybutynin Chloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-851	Oxybutynin Chloride	Oxybutynin Chloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-851	Oxybutynin Chloride	Oxybutynin Chloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-851	Oxybutynin Chloride	Oxybutynin Chloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-931	Oxybutynin Chloride	Oxybutynin Chloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-931	Oxybutynin Chloride	Oxybutynin Chloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-931	Oxybutynin Chloride	Oxybutynin Chloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-931	Oxybutynin Chloride	Oxybutynin Chloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-931	Oxybutynin Chloride	Oxybutynin Chloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-4622	Oxybutynin Chloride	Oxybutynin Chloride	A-S Medication Solutions	ANDA	Current
50090-4622	Oxybutynin Chloride	Oxybutynin Chloride	A-S Medication Solutions	ANDA	Current
50090-4622	Oxybutynin Chloride	Oxybutynin Chloride	A-S Medication Solutions	ANDA	Current
53808-1122	Oxybutynin Chloride	Oxybutynin Chloride	DOH CENTRAL PHARMACY	ANDA	Current
68788-8141	Oxybutynin Chloride	Oxybutynin Chloride	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-2640	Oxybutynin Chloride	Oxybutynin Chloride	REMEDYREPACK INC.	ANDA	Current
70518-2640	Oxybutynin Chloride	Oxybutynin Chloride	REMEDYREPACK INC.	ANDA	Current
70518-2640	Oxybutynin Chloride	Oxybutynin Chloride	REMEDYREPACK INC.	ANDA	Current
71335-1494	Oxybutynin Chloride	Oxybutynin Chloride	Bryant Ranch Prepack	ANDA	Current