Application 200826

Type: ANDA
Sponsor: IMPAX LABS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	URSODIOL	URSODIOL	TABLET;ORAL	250MG	No	No
002	URSODIOL	URSODIOL	TABLET;ORAL	500MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A200826-001	URSODIOL	URSODIOL	250MG	TABLET / ORAL			2011-12-23
A200826-002	URSODIOL	URSODIOL	500MG	TABLET / ORAL			2011-12-23

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 · 86 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	A200826-001	URSODIOL	250MG	TABLET / ORAL		2011-12-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200826-002	URSODIOL	500MG	TABLET / ORAL		2011-12-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200826-001	URSODIOL	250MG	TABLET / ORAL		2011-12-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200826-002	URSODIOL	500MG	TABLET / ORAL		2011-12-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200826-001	URSODIOL	250MG	TABLET / ORAL		2011-12-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200826-002	URSODIOL	500MG	TABLET / ORAL		2011-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200826-001	URSODIOL	250MG	TABLET / ORAL		2011-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200826-002	URSODIOL	500MG	TABLET / ORAL		2011-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200826-001	URSODIOL	250MG	TABLET / ORAL		2011-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200826-002	URSODIOL	500MG	TABLET / ORAL		2011-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200826-001	URSODIOL	250MG	TABLET / ORAL		2011-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200826-002	URSODIOL	500MG	TABLET / ORAL		2011-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200826-001	URSODIOL	250MG	TABLET / ORAL		2011-12-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200826-002	URSODIOL	500MG	TABLET / ORAL		2011-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200826-001	URSODIOL	250MG	TABLET / ORAL		2011-12-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200826-002	URSODIOL	500MG	TABLET / ORAL		2011-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200826-001	URSODIOL	250MG	TABLET / ORAL		2011-12-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200826-002	URSODIOL	500MG	TABLET / ORAL		2011-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200826-001	URSODIOL	250MG	TABLET / ORAL		2011-12-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200826-002	URSODIOL	500MG	TABLET / ORAL		2011-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200826-001	URSODIOL	250MG	TABLET / ORAL		2011-12-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200826-002	URSODIOL	500MG	TABLET / ORAL		2011-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200826-001	URSODIOL	250MG	TABLET / ORAL		2011-12-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200826-002	URSODIOL	500MG	TABLET / ORAL		2011-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200826-001	URSODIOL	250MG	TABLET / ORAL		2011-12-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200826-002	URSODIOL	500MG	TABLET / ORAL		2011-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200826-001	URSODIOL	250MG	TABLET / ORAL		2011-12-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200826-002	URSODIOL	500MG	TABLET / ORAL		2011-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200826-001	URSODIOL	250MG	TABLET / ORAL		2011-12-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200826-002	URSODIOL	500MG	TABLET / ORAL		2011-12-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200826-001	URSODIOL	250MG	TABLET / ORAL		2011-12-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200826-002	URSODIOL	500MG	TABLET / ORAL		2011-12-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200826-001	URSODIOL	250MG	TABLET / ORAL		2011-12-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200826-002	URSODIOL	500MG	TABLET / ORAL		2011-12-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200826-001	URSODIOL	250MG	TABLET / ORAL		2011-12-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200826-002	URSODIOL	500MG	TABLET / ORAL		2011-12-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200826-001	URSODIOL	250MG	TABLET / ORAL		2011-12-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200826-002	URSODIOL	500MG	TABLET / ORAL		2011-12-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200826-001	URSODIOL	250MG	TABLET / ORAL	AB	2011-12-23	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200826-002	URSODIOL	500MG	TABLET / ORAL	AB	2011-12-23	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A200826-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200826-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A200826-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A200826-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200826-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A200826-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200826-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A200826-002	AB	1	`ea99ee380514…`

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 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-1524	URSODIOL	URSODIOL	Impax Generics	ANDA	Current
0115-1524	URSODIOL	URSODIOL	Impax Generics	ANDA	Current
0115-1525	URSODIOL	URSODIOL	Impax Generics	ANDA	Current
0115-1525	URSODIOL	URSODIOL	Impax Generics	ANDA	Current
0115-9933	URSODIOL	URSODIOL	Impax Generics	ANDA	Current
0115-9933	URSODIOL	URSODIOL	Impax Generics	ANDA	Current
0115-9934	URSODIOL	URSODIOL	Impax Generics	ANDA	Current
0115-9934	URSODIOL	URSODIOL	Impax Generics	ANDA	Current
60687-378	Ursodiol	Ursodiol	American Health Packaging	ANDA	Current
60687-378	Ursodiol	Ursodiol	American Health Packaging	ANDA	Current
60687-378	Ursodiol	Ursodiol	American Health Packaging	ANDA	Current
68001-226	Ursodiol	Ursodiol	BluePoint Laboratories	ANDA	Current
68001-227	Ursodiol	Ursodiol	BluePoint Laboratories	ANDA	Current
68001-343	Ursodiol	Ursodiol	BluePoint Laboratories	ANDA	Current
68001-344	Ursodiol	Ursodiol	BluePoint Laboratories	ANDA	Current
68084-892	Ursodiol	Ursodiol	American Health Packaging	ANDA	Current