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 1.

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 · 82 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
2026-02-19 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…`
2022-03-09 01:35 UTC	2022-03	A200826-001	URSODIOL	250MG	TABLET / ORAL		2011-12-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200826-002	URSODIOL	500MG	TABLET / ORAL		2011-12-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200826-001	URSODIOL	250MG	TABLET / ORAL		2011-12-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200826-002	URSODIOL	500MG	TABLET / ORAL		2011-12-23	`782e0a99824c…`

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 1 of 3 · 42 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ursodiol	URSODIOL	AvPAK	5693d709-e894-0144-e063-6294a90a99db	2026-07-27	Warnings, Adverse reactions	Name fallback brand name: Ursodiol generic name: URSODIOL
Ursodiol	URSODIOL	BluePoint Laboratories	a3c98080-0a4d-4a93-8dcb-02ab8533050b	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Ursodiol generic name: URSODIOL
Ursodiol	URSODIOL	Bryant Ranch Prepack	f527a42c-a6ec-4a0b-a3d8-6c7eba38733c	2026-07-13	Warnings, Adverse reactions	Name fallback brand name: Ursodiol generic name: URSODIOL
Ursodiol	URSODIOL	Major Pharmaceuticals	e1f6abfd-2158-4824-b53d-717fbe6de3f9	2026-06-29	Warnings, Adverse reactions	Name fallback brand name: Ursodiol generic name: URSODIOL
URSOLIGN	URSODIOL	Pangea Pharmaceuticals, LLC	3617fb7a-1f57-4276-bebb-ae6ba4252d4e	2026-06-12	Warnings, Adverse reactions	Name fallback generic name: URSODIOL
Ursodiol	URSODIOL	Par Health USA, LLC	1a3a8942-94d4-4292-bf74-0a67d92acb90	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Ursodiol generic name: URSODIOL
URSODIOL	URSODIOL	Golden State Medical Supply, Inc.	fb317988-a4e3-9c9a-e053-6294a90a5990	2026-05-27	Warnings, Adverse reactions	Name fallback brand name: URSODIOL generic name: URSODIOL
Ursodiol	URSODIOL	Bryant Ranch Prepack	b2605f6a-b72d-4773-8d2c-39acfe81e424	2026-04-20	Warnings, Adverse reactions	Name fallback brand name: Ursodiol generic name: URSODIOL
URSODIOL	URSODIOL	Strides Pharma Science Limited	9a6c1928-2d52-4d9a-8e83-f71892a7e98d	2026-03-06	Warnings, Adverse reactions	Name fallback brand name: URSODIOL generic name: URSODIOL
Ursodiol	URSODIOL	Glenmark Pharmaceuticals Inc., USA	fb79b62a-b450-4d7a-be28-5ee4d174fd58	2026-01-27	Warnings, Adverse reactions	Name fallback brand name: Ursodiol generic name: URSODIOL
Ursodiol	URSODIOL	AvKARE	00c47258-aef0-53f6-e063-6294a90af96f	2026-01-19	Adverse reactions	Name fallback brand name: Ursodiol generic name: URSODIOL
Ursodiol	URSODIOL	AvKARE	0c7e1aa2-704c-435d-e063-6394a90a2d08	2026-01-19	Warnings, Adverse reactions	Name fallback brand name: Ursodiol generic name: URSODIOL
Ursodiol	URSODIOL	AvPAK	bbb1f297-1536-9550-e053-2995a90a0d41	2026-01-12	Adverse reactions	Name fallback brand name: Ursodiol generic name: URSODIOL
Ursodiol	URSODIOL	Cardinal Health 107, LLC	61dcaec8-3acb-4ef0-afde-65a66e99afa7	2025-12-05	Warnings, Adverse reactions	Name fallback brand name: Ursodiol generic name: URSODIOL
Ursodiol	URSODIOL	American Health Packaging	a3a90d07-0dac-48fc-829a-759d9333843e	2025-11-13	Warnings, Adverse reactions	Name fallback brand name: Ursodiol generic name: URSODIOL
Ursodiol	URSODIOL	Actavis Pharma, Inc.	a061bb07-a85d-4b08-877f-ce02156f0de7	2025-08-14	Warnings, Adverse reactions	Name fallback brand name: Ursodiol generic name: URSODIOL
URSODIOL	URSODIOL	Strides Pharma Science Limited	9d666bbc-98c4-445f-a5a2-cad1bcccde4e	2025-08-10	Warnings, Adverse reactions	Name fallback brand name: URSODIOL generic name: URSODIOL
Ursodiol	URSOSIOL	PD-Rx Pharmaceuticals, Inc.	d89c9e1e-a115-4a01-9275-74d6cd8cf285	2025-07-17	Warnings, Adverse reactions	Name fallback brand name: Ursodiol
Ursodiol	URSODIOL	Aurobindo Pharma Limited	631339fc-548d-4cd5-8cf3-60e1590f79f6	2025-07-01	Warnings, Adverse reactions	Name fallback brand name: Ursodiol generic name: URSODIOL
Ursodiol	URSODIOL	NorthStar Rx LLC	dd0346e2-5ff3-4208-ad88-d09182684603	2025-07-01	Warnings, Adverse reactions	Name fallback brand name: Ursodiol generic name: URSODIOL

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