Application 212798

Type: ANDA
Sponsor: LEADING PHARMA LLC

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 42.

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
A212798-001	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB		2020-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212798-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212798-001	OXYBUTYNIN CHLORIDE	5MG	TABLET / ORAL	AB	2020-04-06	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A212798-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212798-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212798-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212798-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212798-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212798-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212798-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212798-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212798-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212798-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212798-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212798-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212798-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212798-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212798-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212798-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212798-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212798-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212798-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212798-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212798-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212798-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212798-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212798-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212798-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212798-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212798-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212798-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212798-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212798-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212798-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212798-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212798-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212798-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212798-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212798-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212798-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212798-001	AB	1	`a50c72e98297…`

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	Redpharm Drug	fc4cfbe6-a940-41c0-e053-6294a90adb14	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212798 application number: ANDA212798
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	A-S Medication Solutions	83522acd-0ecc-46ac-a018-a3205ba096ff	2023-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212798 application number: ANDA212798 ndc (product): 50090-6199
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	5b72d34e-ae57-4459-ba2c-3bae8a69c5c1	2023-10-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212798 application number: ANDA212798
OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	Leading Pharma, LLC	b73b8338-8045-448f-87a6-3d289227d00e	2022-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212798 application number: ANDA212798 ndc (product): 69315-182

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-6199	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	A-S Medication Solutions	ANDA	Current
69315-182	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	Leading Pharma, LLC	ANDA	Current
69315-182	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	Leading Pharma, LLC	ANDA	Current
70518-3473	OXYBUTYNIN CHLORIDE	OXYBUTYNIN CHLORIDE	REMEDYREPACK INC.	ANDA	Current