Application 212452

Type: ANDA
Sponsor: EYWA PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	URSODIOL	URSODIOL	CAPSULE;ORAL	300MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A212452-001	URSODIOL	URSODIOL	300MG	CAPSULE / ORAL	AB		2019-10-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212452-001	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.

Product history page 1 of 2 · 41 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	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212452-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2019-10-30	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A212452-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A212452-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A212452-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212452-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212452-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212452-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212452-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212452-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212452-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212452-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212452-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212452-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212452-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212452-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212452-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212452-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212452-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212452-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212452-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A212452-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A212452-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212452-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212452-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A212452-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A212452-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A212452-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A212452-001	AB	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212452-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212452-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212452-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212452-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212452-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212452-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212452-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212452-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212452-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212452-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212452-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212452-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212452-001	AB	1	`cb3db0bc1861…`

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 2 of 3 · 42 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ursodiol	URSOSIOL	KVK-Tech, Inc.	fff2640b-b704-4303-acae-8647fce58a08	2025-05-14	Warnings, Adverse reactions	Name fallback brand name: Ursodiol
Ursodiol	URSODIOL	Amneal Pharmaceuticals NY LLC	1027b933-f64f-4a43-996f-a676b5f72da0	2025-04-24	Adverse reactions	Name fallback brand name: Ursodiol generic name: URSODIOL
Ursodiol	URSODIOL	Major Pharmaceuticals	c9aa0223-3ea4-4cb7-b53b-f35e5a04cec7	2025-01-09	Warnings, Adverse reactions	Name fallback brand name: Ursodiol generic name: URSODIOL
Ursodiol	URSODIOL	PuraCap Laboratories, LLC	9d7f26d5-d8a9-4610-8d78-80ca3d442a79	2024-12-19	Adverse reactions	Name fallback brand name: Ursodiol generic name: URSODIOL
Ursodiol	URSODIOL	Bryant Ranch Prepack	46cfd68f-9a6e-4a00-a3e7-11d130b571fe	2024-10-03	Warnings, Adverse reactions	Name fallback brand name: Ursodiol generic name: URSODIOL
Ursodiol	URSODIOL	Bryant Ranch Prepack	be811c61-5f48-4b03-94b6-e6941b595621	2024-05-31	Warnings, Adverse reactions	Name fallback brand name: Ursodiol generic name: URSODIOL
Ursodiol	URSODIOL	Zydus Pharmaceuticals (USA) Inc.	47beccad-d217-4ae5-9d57-79bf8d0704d8	2024-03-26	Warnings, Adverse reactions	Name fallback brand name: Ursodiol generic name: URSODIOL
Ursodiol	URSODIOL	Zydus Pharmaceuticals (USA) Inc.	55c1556b-8b47-479a-979b-fd61bdd27c7f	2024-03-22	Warnings, Adverse reactions	Name fallback brand name: Ursodiol generic name: URSODIOL
Ursodiol	URSODIOL	Laurus Labs Limited	6be8e383-37fa-4e0a-b9fc-3976a8be1d2f	2024-03-11	Warnings, Adverse reactions	Name fallback brand name: Ursodiol generic name: URSODIOL
Ursodiol	URSODIOL	Zydus Lifesciences Limited	6163fc42-5910-4e19-9e32-3d8e81f50128	2024-02-15	Warnings, Adverse reactions	Name fallback brand name: Ursodiol generic name: URSODIOL
Ursodiol 200 mg	URSODIOL	FH2 Pharma LLC	476179dc-b410-4305-881b-470511765647	2023-12-31	Adverse reactions	Name fallback generic name: URSODIOL
Ursodiol	URSODIOL	Bryant Ranch Prepack	5e6ced5f-b8ef-4e6b-a7c1-730bac650c5b	2023-12-07	Warnings, Adverse reactions	Name fallback brand name: Ursodiol generic name: URSODIOL
Ursodiol	URSODIOL	Bryant Ranch Prepack	011ede7f-bb4d-45f7-8041-9feb4aa2ba7d	2023-12-07	Adverse reactions	Name fallback brand name: Ursodiol generic name: URSODIOL
Ursodiol	URSODIOL	Chartwell RX, LLC	31ff3961-3ef1-4ec3-b742-beb4b96de795	2023-10-05	Adverse reactions	Name fallback brand name: Ursodiol generic name: URSODIOL
Ursodiol	URSODIOL	VGYAAN Pharmaceuticals LLC	db43354d-4d77-4241-af4e-5cfa6f6cd296	2023-09-25	Adverse reactions	Name fallback brand name: Ursodiol generic name: URSODIOL
Ursodiol	URSODIOL	Epic Pharma, LLC	e47b49ca-bde9-448a-bf61-f943c2aa5b8e	2023-08-10	Warnings, Adverse reactions	Name fallback brand name: Ursodiol generic name: URSODIOL
Ursodiol	URSODIOL	Actavis Pharma, Inc.	a061bb07-a85d-4b08-877f-ce02156f0de7	2023-07-31	Warnings, Adverse reactions	Name fallback brand name: Ursodiol generic name: URSODIOL
Ursodiol	URSODIOL	Lannett Company, Inc.	2e799e93-b5a0-40f7-95c5-b40d8a948a0d	2023-07-26	Adverse reactions	Name fallback brand name: Ursodiol generic name: URSODIOL
Ursodiol	URSODIOL	Zydus Lifesciences Limited	792d8b51-3815-44d2-a20e-b494a9d0e055	2023-06-15	Warnings, Adverse reactions	Name fallback brand name: Ursodiol generic name: URSODIOL
Reltone 200 mg	URSODIOL	Intra-Sana Laboratories	d1c28b0b-8f3c-4d60-8182-24a4c659d762	2023-01-16	Adverse reactions	Name fallback generic name: URSODIOL

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63629-1173	Ursodiol	Ursodiol	Bryant Ranch Prepack	ANDA	Current
63629-1173	Ursodiol	Ursodiol	Bryant Ranch Prepack	ANDA	Current
71930-015	Ursodiol	Ursodiol	Eywa Pharma Inc	ANDA	Current
72789-205	Ursodiol	Ursodiol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-205	Ursodiol	Ursodiol	PD-Rx Pharmaceuticals, Inc.	ANDA	Current