Application 209025

Type: ANDA
Sponsor: ARISE

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
002	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	TABLET;ORAL	2.5MG	No	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A209025-001	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21
A209025-002	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	2.5MG	TABLET / ORAL	AB	RS	2023-02-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A209025-001	AB
A209025-002	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 · 64 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209025-002	OXYBUTYNIN CHLORIDE	2.5MG	TABLET / ORAL		RS	2023-02-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209025-002	OXYBUTYNIN CHLORIDE	2.5MG	TABLET / ORAL		RS	2023-02-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209025-002	OXYBUTYNIN CHLORIDE	2.5MG	TABLET / ORAL		RS	2023-02-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209025-002	OXYBUTYNIN CHLORIDE	2.5MG	TABLET / ORAL		RS	2023-02-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209025-002	OXYBUTYNIN CHLORIDE	2.5MG	TABLET / ORAL		RS	2023-02-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209025-002	OXYBUTYNIN CHLORIDE	2.5MG	TABLET / ORAL		RS	2023-02-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209025-002	OXYBUTYNIN CHLORIDE	2.5MG	TABLET / ORAL		RS	2023-02-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209025-002	OXYBUTYNIN CHLORIDE	2.5MG	TABLET / ORAL		RS	2023-02-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209025-002	OXYBUTYNIN CHLORIDE	2.5MG	TABLET / ORAL		RS	2023-02-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209025-002	OXYBUTYNIN CHLORIDE	2.5MG	TABLET / ORAL		RS	2023-02-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209025-002	OXYBUTYNIN CHLORIDE	2.5MG	TABLET / ORAL		RS	2023-02-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209025-002	OXYBUTYNIN CHLORIDE	2.5MG	TABLET / ORAL		RS	2023-02-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209025-002	OXYBUTYNIN CHLORIDE	2.5MG	TABLET / ORAL		RS	2023-02-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209025-002	OXYBUTYNIN CHLORIDE	2.5MG	TABLET / ORAL		RS	2023-02-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209025-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-12-21	`b00525d2431f…`

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
2026-02-19 14:30 UTC	2026-02	A209025-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209025-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209025-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209025-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209025-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209025-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209025-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209025-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209025-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209025-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209025-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209025-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209025-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209025-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209025-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209025-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209025-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209025-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209025-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209025-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209025-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209025-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209025-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209025-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209025-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209025-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209025-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209025-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209025-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209025-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209025-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209025-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209025-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209025-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209025-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209025-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209025-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209025-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209025-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209025-001	AB	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 1 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	RISING PHARMA HOLDINGS, INC.	9578b6b8-5b9d-4263-9142-39b2c7216b85	2026-04-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209025 application number: ANDA209025
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	A-S Medication Solutions	44990ed6-b8e7-40f5-b636-e848024ec6d8	2025-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209025 application number: ANDA209025
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	A-S Medication Solutions	0697b3cf-b146-47c0-b5a5-5905ae8d1c97	2025-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209025 application number: ANDA209025
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	PD-Rx Pharmaceuticals, Inc.	8bd5dce0-d56a-4e64-8de7-e7cd7775526b	2025-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209025 application number: ANDA209025
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	PD-Rx Pharmaceuticals, Inc.	3a319017-4e25-402e-8ba0-63b9f1eb707e	2025-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209025 application number: ANDA209025
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	Bryant Ranch Prepack	f26e590d-956e-493b-a6ac-6056aeeaf411	2024-08-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209025 application number: ANDA209025 ndc (product): 71335-1014
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	RISING PHARMA HOLDINGS, INC.	f8ed80f2-6c3d-4d7f-b761-c2447973c1f9	2024-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209025 application number: ANDA209025 ndc (product): 64980-431

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
64980-431	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	Rising Pharmaceuticals, Inc.	ANDA	Current
68071-4395	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7234	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7234	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7234	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-1294	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-1294	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	REMEDYREPACK INC.	ANDA	Current
71335-1014	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	Bryant Ranch Prepack	ANDA	Current
71335-1014	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	Bryant Ranch Prepack	ANDA	Current