Application 209823

Type: ANDA
Sponsor: NOVITIUM PHARMA

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
A209823-001	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	2017-10-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209823-001	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	2017-10-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	2017-10-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209823-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2017-10-23	`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	A209823-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209823-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209823-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209823-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209823-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209823-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209823-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209823-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209823-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209823-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209823-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209823-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209823-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209823-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209823-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209823-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209823-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209823-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209823-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209823-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209823-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209823-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209823-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209823-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209823-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209823-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209823-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209823-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209823-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209823-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209823-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209823-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209823-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209823-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209823-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209823-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209823-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209823-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209823-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A209823-001	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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Northwind Health Company, LLC	f330b7a0-bbe0-0f00-e053-2a95a90a37b8	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209823 application number: ANDA209823
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	VERITYRX, LLC	427b6ffb-3ff4-932f-e063-6394a90ae8b9	2025-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209823 application number: ANDA209823
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Major Pharmaceuticals	7769ad3d-6228-4b2d-8f44-4efe990d3fad	2025-09-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209823 application number: ANDA209823 ndc (product): 0904-7027
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Cardinal Health 107, LLC	8455b543-81ce-4522-ae9b-8396f944945c	2025-08-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209823 application number: ANDA209823
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Golden State Medical Supply, Inc.	6f409d7f-b064-1363-e053-2a91aa0a3a14	2024-12-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209823 application number: ANDA209823 ndc (product): 51407-099
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	ANI Pharmaceuticals, Inc.	3b1f5585-9b33-4a96-bf33-8e6bab14bf0c	2024-11-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209823 application number: ANDA209823 ndc (product): 70954-005
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	NuCare Pharmaceuticals,Inc.	8e830697-a6d3-13ed-e053-2995a90acb11	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209823 application number: ANDA209823 ndc (product): 66267-642
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	A-S Medication Solutions	5e3b454b-6d3c-418b-8ac2-b0e17f018bbf	2023-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209823 application number: ANDA209823
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	A-S Medication Solutions	afc6a3aa-e43d-4f10-bdbd-570a149bf9db	2023-12-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209823 application number: ANDA209823
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	d2bb6927-5fbf-49ca-a891-d701bff1c812	2023-05-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209823 application number: ANDA209823 ndc (product): 71610-277

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-7027	Oxybutynin Chloride	Oxybutynin Chloride	Major Pharmaceuticals	ANDA	Current
10135-640	Oxybutynin Chloride	Oxybutynin Chloride	Marlex Pharmaceuticals Inc	ANDA	Current
10135-640	Oxybutynin Chloride	Oxybutynin Chloride	Marlex Pharmaceuticals Inc	ANDA	Current
51407-099	Oxybutynin Chloride	Oxybutynin Chloride	Golden State Medical Supply Inc.	ANDA	Current
51407-099	Oxybutynin Chloride	Oxybutynin Chloride	Golden State Medical Supply Inc.	ANDA	Current
51407-099	Oxybutynin Chloride	Oxybutynin Chloride	Golden State Medical Supply, Inc.	ANDA	Current
66267-642	Oxybutynin Chloride	Oxybutynin Chloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
66267-642	Oxybutynin Chloride	Oxybutynin Chloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-1941	Oxybutynin Chloride	Oxybutynin Chloride	REMEDYREPACK INC.	ANDA	Current
70518-1941	Oxybutynin Chloride	Oxybutynin Chloride	REMEDYREPACK INC.	ANDA	Current
70518-1941	Oxybutynin Chloride	Oxybutynin Chloride	REMEDYREPACK INC.	ANDA	Current
70518-1941	Oxybutynin Chloride	Oxybutynin Chloride	REMEDYREPACK INC.	ANDA	Current
70518-1941	Oxybutynin Chloride	Oxybutynin Chloride	REMEDYREPACK INC.	ANDA	Current
70518-1941	Oxybutynin Chloride	Oxybutynin Chloride	REMEDYREPACK INC.	ANDA	Current
70518-1941	Oxybutynin Chloride	Oxybutynin Chloride	REMEDYREPACK INC.	ANDA	Current
70934-529	Oxybutynin Chloride	Oxybutynin Chloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-909	Oxybutynin Chloride	Oxybutynin Chloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-909	Oxybutynin Chloride	Oxybutynin Chloride	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70954-005	Oxybutynin Chloride	Oxybutynin Chloride	Novitium Pharma LLC	ANDA	Current
70954-005	Oxybutynin Chloride	Oxybutynin Chloride	Novitium Pharma LLC	ANDA	Current
71335-1160	Oxybutynin Chloride	Oxybutynin Chloride	Bryant Ranch Prepack	ANDA	Current
71335-1160	Oxybutynin Chloride	Oxybutynin Chloride	Bryant Ranch Prepack	ANDA	Current
71610-277	Oxybutynin Chloride	Oxybutynin Chloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current