Application 071655

Type: ANDA
Sponsor: TEVA PHARMS USA

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
A071655-001	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		1988-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A071655-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071655-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	1988-11-14	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A071655-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A071655-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A071655-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A071655-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A071655-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A071655-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A071655-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A071655-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A071655-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A071655-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A071655-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A071655-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A071655-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A071655-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A071655-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A071655-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A071655-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A071655-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A071655-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A071655-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A071655-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A071655-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A071655-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A071655-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A071655-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A071655-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A071655-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A071655-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A071655-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A071655-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A071655-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A071655-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A071655-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A071655-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A071655-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A071655-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A071655-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A071655-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A071655-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A071655-001	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	direct rx	b3d6d2a8-97c4-5bad-e053-2a95a90a155d	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071655 application number: ANDA071655 ndc (product): 72189-130
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Bryant Ranch Prepack	246d2f79-8ab5-4023-9068-1451b695ac16	2024-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071655 application number: ANDA071655 ndc (product): 71335-0519
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Teva Pharmaceuticals USA, Inc.	cb7aba8d-6913-4f57-8eb4-c6d6ff0b2a29	2024-09-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071655 application number: ANDA071655 ndc (product): 50111-456
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Proficient Rx LP	e3f0c249-8085-4979-823a-820e233a284f	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 071655 application number: ANDA071655 ndc (product): 63187-749

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 29 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-2821	Oxybutynin Chloride	Oxybutynin Chloride	Major Pharmaceuticals	ANDA	Current
0904-2821	Oxybutynin Chloride	Oxybutynin Chloride	Major Pharmaceuticals	ANDA	Current
0904-2821	Oxybutynin Chloride	Oxybutynin Chloride	Major Pharmaceuticals	ANDA	Current
10544-559	Oxybutynin Chloride	Oxybutynin Chloride	Blenheim Pharmacal, Inc.	ANDA	Current
35356-958	Oxybutynin Chloride	Oxybutynin Chloride	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
50090-0318	Oxybutynin Chloride	Oxybutynin Chloride	A-S Medication Solutions	ANDA	Current
50090-0318	Oxybutynin Chloride	Oxybutynin Chloride	A-S Medication Solutions	ANDA	Current
50111-456	Oxybutynin Chloride	Oxybutynin Chloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50111-456	Oxybutynin Chloride	Oxybutynin Chloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50111-456	Oxybutynin Chloride	Oxybutynin Chloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50111-456	Oxybutynin Chloride	Oxybutynin Chloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50111-456	Oxybutynin Chloride	Oxybutynin Chloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
50436-4777	Oxybutynin Chloride	Oxybutynin Chloride	Unit Dose Services	ANDA	Current
53808-0747	Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	State of Florida DOH Central Pharmacy	ANDA	Current
55154-0657	Oxybutynin Chloride	Oxybutynin Chloride	Cardinal Health	ANDA	Current
55154-0657	Oxybutynin Chloride	Oxybutynin Chloride	Cardinal Health	ANDA	Current
55154-0657	Oxybutynin Chloride	Oxybutynin Chloride	Cardinal Health	ANDA	Current
63187-749	Oxybutynin Chloride	Oxybutynin Chloride	Proficient Rx LP	ANDA	Current
63187-749	Oxybutynin Chloride	Oxybutynin Chloride	Proficient Rx LP	ANDA	Current
63187-749	Oxybutynin Chloride	Oxybutynin Chloride	Proficient Rx LP	ANDA	Current
63187-749	Oxybutynin Chloride	Oxybutynin Chloride	Proficient Rx LP	ANDA	Current
67544-569	Oxybutynin Chloride	Oxybutynin Chloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
68071-1875	Oxybutynin Chloride	Oxybutynin Chloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-1875	Oxybutynin Chloride	Oxybutynin Chloride	NuCare Pharmaceuticals, Inc.	ANDA	Current
70518-1052	Oxybutynin Chloride	Oxybutynin Chloride	REMEDYREPACK INC.	ANDA	Current
70518-1052	Oxybutynin Chloride	Oxybutynin Chloride	REMEDYREPACK INC.	ANDA	Current
71335-0519	Oxybutynin Chloride	Oxybutynin Chloride	Bryant Ranch Prepack	ANDA	Current
71335-0519	Oxybutynin Chloride	Oxybutynin Chloride	Bryant Ranch Prepack	ANDA	Current
72189-130	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	direct rx	ANDA	Current