Application 214415

Type: ANDA
Sponsor: RUBICON

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 43.

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	Approval date
A214415-001	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27
A214415-002	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27
A214415-003	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214415-001	AB
A214415-002	AB
A214415-003	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 3 · 114 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
2026-09-14 22:38:34	2026-08	A214415-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214415-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A214415-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214415-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214415-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A214415-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214415-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214415-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A214415-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214415-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214415-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214415-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214415-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214415-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A214415-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214415-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214415-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214415-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214415-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214415-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214415-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214415-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214415-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214415-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214415-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214415-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214415-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214415-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214415-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214415-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214415-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214415-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214415-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214415-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214415-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A214415-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214415-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214415-002	OXYBUTYNIN CHLORIDE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214415-003	OXYBUTYNIN CHLORIDE	15MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214415-001	OXYBUTYNIN CHLORIDE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-10-27	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 114 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214415-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214415-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214415-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214415-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214415-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214415-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214415-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A214415-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214415-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214415-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214415-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214415-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214415-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A214415-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A214415-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214415-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A214415-003	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A214415-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214415-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A214415-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A214415-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A214415-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A214415-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214415-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214415-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A214415-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A214415-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A214415-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A214415-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A214415-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A214415-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A214415-003	AB	1	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214415-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214415-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214415-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214415-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214415-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A214415-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214415-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A214415-002	AB	1	`ea1830bbd6c7…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxybutynin Chloride	OXYBUTYNIN CHLORIDE	Advagen Pharma Limited	7bd31561-4c76-4c6b-819b-492549886673	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214415 application number: ANDA214415 ndc (product): 72888-030 ndc (product): 72888-031 ndc (product): 72888-032

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72888-030	Oxybutynin Chloride	Oxybutynin Chloride	Advagen Pharma Limited	ANDA	Current
72888-030	Oxybutynin Chloride	Oxybutynin Chloride	Advagen Pharma Limited	ANDA	Current
72888-030	Oxybutynin Chloride	Oxybutynin Chloride	Advagen Pharma Limited	ANDA	Current
72888-031	Oxybutynin Chloride	Oxybutynin Chloride	Advagen Pharma Limited	ANDA	Current
72888-031	Oxybutynin Chloride	Oxybutynin Chloride	Advagen Pharma Limited	ANDA	Current
72888-031	Oxybutynin Chloride	Oxybutynin Chloride	Advagen Pharma Limited	ANDA	Current
72888-032	Oxybutynin Chloride	Oxybutynin Chloride	Advagen Pharma Limited	ANDA	Current
72888-032	Oxybutynin Chloride	Oxybutynin Chloride	Advagen Pharma Limited	ANDA	Current
72888-032	Oxybutynin Chloride	Oxybutynin Chloride	Advagen Pharma Limited	ANDA	Current