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 1.

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 · 123 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
2026-02-19 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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202332-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202332-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202332-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB		2017-06-26	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	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…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202332-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202332-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202332-001	AB	1	`8072bd15b7f6…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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