Application 208165

Type: ANDA
Sponsor: STRIDES 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 1.

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
A208165-001	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2020-12-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208165-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2020-12-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2020-12-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2020-12-17	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2020-12-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2020-12-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL		2020-12-17	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208165-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-12-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208165-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208165-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208165-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208165-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208165-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208165-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208165-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208165-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208165-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208165-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208165-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208165-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208165-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208165-001	AB	1	`8072bd15b7f6…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208165-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208165-001	AB	1	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208165-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208165-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208165-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208165-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208165-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208165-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208165-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208165-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208165-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208165-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208165-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208165-001	AB	1	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A208165-001	AB	1	`a50c72e98297…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Coupler LLC	55f618d1-4463-3200-e063-6394a90a89a8	2026-07-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208165 application number: ANDA208165
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Strides Pharma Science Limited	ac10c7b7-d0cb-4068-93e2-c0e51f15866e	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208165 application number: ANDA208165 ndc (product): 64380-781
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	American Health Packaging	4574b227-9726-4798-bac2-83bfb9616f09	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208165 application number: ANDA208165
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	9a551ec5-7e80-47c9-a7b9-f458c1478174	2026-02-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208165 application number: ANDA208165 ndc (product): 23155-810
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	AvKARE	3418ca19-feb0-9821-e063-6394a90ae819	2025-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208165 application number: ANDA208165

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
23155-810	Oxybutynin Chloride	Oxybutynin Chloride	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
64380-781	Oxybutynin Chloride	Oxybutynin Chloride	Strides Pharma Science Limited	ANDA	Current