Application 202332

Type: ANDA
Sponsor: ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	TABLET, EXTENDED RELEASE;ORAL	5MG	No	No
002	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	TABLET, EXTENDED RELEASE;ORAL	10MG	No	No
003	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	TABLET, EXTENDED RELEASE;ORAL	15MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202332-001	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26
A202332-002	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26
A202332-003	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2017-06-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A202332-001	AB
A202332-002	AB
A202332-003	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 4 · 126 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	A202332-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202332-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202332-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2017-06-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202332-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202332-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202332-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2017-06-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202332-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202332-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202332-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202332-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202332-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202332-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202332-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202332-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202332-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202332-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202332-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202332-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202332-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202332-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202332-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202332-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202332-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202332-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202332-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202332-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202332-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202332-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202332-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202332-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202332-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202332-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202332-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202332-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202332-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202332-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202332-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202332-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202332-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202332-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A202332-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202332-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202332-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202332-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202332-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202332-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202332-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202332-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202332-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202332-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202332-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202332-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202332-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202332-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202332-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202332-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202332-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202332-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202332-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202332-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202332-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202332-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202332-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202332-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202332-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202332-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202332-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202332-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202332-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202332-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202332-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202332-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202332-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202332-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202332-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202332-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202332-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202332-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202332-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202332-001	AB	1	`1e350fbaab3a…`

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	OXYBUTYNIN	Zydus Lifesciences Limited	f405a774-bd91-4513-b7c7-c44f0596d988	2024-12-03		Exact identifier application applno (ANDA): 202332 application number: ANDA202332 ndc (product): 70771-1087 ndc (product): 70771-1086 ndc (product): 70771-1088
oxybutynin	OXYBUTYNIN	NCS HealthCare of KY, LLC dba Vangard Labs	ec4fd95f-16dc-4acf-b560-b67b7aaef08b	2024-09-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202332 application number: ANDA202332 ndc (product): 0615-8220
oxybutynin	OXYBUTYNIN	NCS HealthCare of KY, LLC dba Vangard Labs	ed10f0c9-23d6-4ded-b17f-ed474632a965	2024-08-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202332 application number: ANDA202332 ndc (product): 0615-8219
oxybutynin	OXYBUTYNIN	Zydus Pharmaceuticals USA Inc.	c042bf06-79a3-4dc7-ae05-3ef3cfae9d44	2023-11-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202332 application number: ANDA202332 ndc (product): 68382-256 ndc (product): 68382-257 ndc (product): 68382-255
oxybutynin	OXYBUTYNIN	A-S Medication Solutions	1f95920c-5dc2-44e4-b61d-b2c5e05390ba	2023-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202332 application number: ANDA202332 ndc (product): 50090-5353

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0615-8219	oxybutynin	oxybutynin	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8220	Oxybutynin	Oxybutynin	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
50090-5352	oxybutynin	oxybutynin	A-S Medication Solutions	ANDA	Current
50090-5352	oxybutynin	oxybutynin	A-S Medication Solutions	ANDA	Current
50090-5353	oxybutynin	oxybutynin	A-S Medication Solutions	ANDA	Current
50090-5353	oxybutynin	oxybutynin	A-S Medication Solutions	ANDA	Current
68382-255	oxybutynin	oxybutynin	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-255	oxybutynin	oxybutynin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-255	oxybutynin	oxybutynin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-255	oxybutynin	oxybutynin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-255	oxybutynin	oxybutynin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-256	oxybutynin	oxybutynin	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-256	oxybutynin	oxybutynin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-256	oxybutynin	oxybutynin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-256	oxybutynin	oxybutynin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-256	oxybutynin	oxybutynin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-257	oxybutynin	oxybutynin	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-257	oxybutynin	oxybutynin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-257	oxybutynin	oxybutynin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-257	oxybutynin	oxybutynin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-257	oxybutynin	oxybutynin	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70518-1457	oxybutynin	oxybutynin	REMEDYREPACK INC.	ANDA	Current
70518-1457	oxybutynin	oxybutynin	REMEDYREPACK INC.	ANDA	Current
70518-2331	oxybutynin	oxybutynin	REMEDYREPACK INC.	ANDA	Current
70771-1086	oxybutynin	oxybutynin	Cadila Healthcare Limited	ANDA	Current
70771-1086	oxybutynin	oxybutynin	Cadila Healthcare Limited	ANDA	Current
70771-1086	oxybutynin	oxybutynin	Cadila Healthcare Limited	ANDA	Current
70771-1086	oxybutynin	oxybutynin	Cadila Healthcare Limited	ANDA	Current
70771-1086	oxybutynin	oxybutynin	Zydus Lifesciences Limited	ANDA	Current
70771-1087	oxybutynin	oxybutynin	Cadila Healthcare Limited	ANDA	Current
70771-1087	oxybutynin	oxybutynin	Cadila Healthcare Limited	ANDA	Current
70771-1087	oxybutynin	oxybutynin	Cadila Healthcare Limited	ANDA	Current
70771-1087	oxybutynin	oxybutynin	Cadila Healthcare Limited	ANDA	Current
70771-1087	oxybutynin	oxybutynin	Zydus Lifesciences Limited	ANDA	Current
70771-1088	oxybutynin	oxybutynin	Cadila Healthcare Limited	ANDA	Current
70771-1088	oxybutynin	oxybutynin	Cadila Healthcare Limited	ANDA	Current
70771-1088	oxybutynin	oxybutynin	Cadila Healthcare Limited	ANDA	Current
70771-1088	oxybutynin	oxybutynin	Cadila Healthcare Limited	ANDA	Current
70771-1088	oxybutynin	oxybutynin	Zydus Lifesciences Limited	ANDA	Current
71335-0974	oxybutynin	oxybutynin	Bryant Ranch Prepack	ANDA	Current
71335-0974	oxybutynin	oxybutynin	Bryant Ranch Prepack	ANDA	Current
71335-0974	oxybutynin	oxybutynin	Bryant Ranch Prepack	ANDA	Current