Application 075079

Type: ANDA
Sponsor: VINTAGE PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	TABLET;ORAL	5MG	No	Yes
002	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	TABLET;ORAL	2.5MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A075079-001	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		1997-10-31
A075079-002	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	2.5MG	TABLET / ORAL	AB		2026-03-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A075079-001	AB
A075079-002	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 · 44 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	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		1997-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075079-002	OXYBUTYNIN CHLORIDE	2.5MG	TABLET / ORAL	AB		2026-03-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		1997-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075079-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	RS	1997-10-31	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 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	A075079-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075079-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075079-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075079-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075079-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075079-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075079-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075079-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075079-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075079-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075079-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075079-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075079-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075079-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075079-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075079-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075079-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075079-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075079-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075079-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075079-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075079-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075079-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075079-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075079-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075079-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075079-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075079-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075079-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075079-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075079-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075079-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075079-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075079-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075079-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075079-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075079-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075079-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075079-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075079-001	AB	1	`f41ea6bd6efb…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Strides Pharma Science Limited	9ede5def-d185-4e40-9c10-8663ac654caf	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075079 application number: ANDA075079 ndc (product): 64380-162
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	2425f49f-ade3-5178-e063-6294a90adfac	2024-10-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075079 application number: ANDA075079

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 40 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0603-4975	Oxybutynin Chloride	oxybutynin chloride	Par Pharmaceutical	ANDA	Current
0603-4975	Oxybutynin Chloride	oxybutynin chloride	Par Pharmaceutical, Inc.	ANDA	Current
0615-3512	Oxybutynin Chloride	Oxybutynin Chloride	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-3512	Oxybutynin Chloride	Oxybutynin Chloride	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
0615-8428	Oxybutynin Chloride	oxybutynin chloride	NCS HealthCare of KY, LLC dba Vangard Labs	ANDA	Current
10544-518	Oxybutynin Chloride	oxybutynin chloride	Blenheim Pharmacal, Inc.	ANDA	Current
21695-406	Oxybutynin Chloride	oxybutynin chloride	Rebel Distributors Corp.	ANDA	Current
33261-342	Oxybutynin Chloride	oxybutynin chloride	Aidarex Pharmaceuticals LLC	ANDA	Current
42291-914	Oxybutynin Chloride	oxybutynin chloride	AvKARE	ANDA	Current
43063-145	Oxybutynin Chloride	oxybutynin chloride	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43353-367	Oxybutynin Chloride	oxybutynin chloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
43353-367	Oxybutynin Chloride	oxybutynin chloride	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
50090-2049	Oxybutynin Chloride	oxybutynin chloride	A-S Medication Solutions	ANDA	Current
50090-2049	Oxybutynin Chloride	oxybutynin chloride	A-S Medication Solutions	ANDA	Current
53808-0618	Oxybutynin Chloride	oxybutynin chloride	State of Florida DOH Central Pharmacy	ANDA	Current
55154-6647	Oxybutynin Chloride	oxybutynin chloride	Cardinal Health	ANDA	Current
55154-6647	Oxybutynin Chloride	oxybutynin chloride	Cardinal Health	ANDA	Current
55154-6647	Oxybutynin Chloride	oxybutynin chloride	Cardinal Health	ANDA	Current
60687-670	Oxybutynin Chloride	oxybutynin chloride	American Health Packaging	ANDA	Current
63629-1354	Oxybutynin Chloride	oxybutynin chloride	Bryant Ranch Prepack	ANDA	Current
63629-1354	Oxybutynin Chloride	oxybutynin chloride	Bryant Ranch Prepack	ANDA	Current
63629-2244	Oxybutynin Chloride	oxybutynin chloride	Bryant Ranch Prepack	ANDA	Current
63629-2244	Oxybutynin Chloride	oxybutynin chloride	Bryant Ranch Prepack	ANDA	Current
63629-2245	Oxybutynin Chloride	oxybutynin chloride	Bryant Ranch Prepack	ANDA	Current
63629-2245	Oxybutynin Chloride	oxybutynin chloride	Bryant Ranch Prepack	ANDA	Current
63629-2246	Oxybutynin Chloride	oxybutynin chloride	Bryant Ranch Prepack	ANDA	Current
63629-2246	Oxybutynin Chloride	oxybutynin chloride	Bryant Ranch Prepack	ANDA	Current
63629-8996	Oxybutynin Chloride	oxybutynin chloride	Bryant Ranch Prepack	ANDA	Current
64380-162	Oxybutynin Chloride	oxybutynin chloride	Strides Pharma Science Limited	ANDA	Current
64380-162	Oxybutynin Chloride	oxybutynin chloride	Strides Pharma Science Limited	ANDA	Current
64380-162	Oxybutynin Chloride	oxybutynin chloride	Strides Pharma Science Limited	ANDA	Current
68071-1959	Oxybutynin Chloride	oxybutynin chloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68084-400	Oxybutynin Chloride	oxybutynin chloride	American Health Packaging	ANDA	Current
68084-400	Oxybutynin Chloride	oxybutynin chloride	American Health Packaging	ANDA	Current
68084-400	Oxybutynin Chloride	oxybutynin chloride	American Health Packaging	ANDA	Current
68788-6402	Oxybutynin Chloride	oxybutynin chloride	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0856	Oxybutynin Chloride	oxybutynin chloride	REMEDYREPACK INC.	ANDA	Current
70518-0856	Oxybutynin Chloride	oxybutynin chloride	REMEDYREPACK INC.	ANDA	Current
70518-1030	Oxybutynin Chloride	oxybutynin chloride	REMEDYREPACK INC.	ANDA	Current
70518-1030	Oxybutynin Chloride	oxybutynin chloride	REMEDYREPACK INC.	ANDA	Current