Application 202540

Type: ANDA
Sponsor: PAR PHARM

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 42.

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
A202540-001	URSODIOL	URSODIOL	250MG	TABLET / ORAL	AB		2013-02-14
A202540-002	URSODIOL	URSODIOL	500MG	TABLET / ORAL	AB		2013-02-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A202540-001	AB
A202540-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202540-001	URSODIOL	250MG	TABLET / ORAL	AB	2013-02-14	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202540-002	URSODIOL	500MG	TABLET / ORAL	AB	2013-02-14	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A202540-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202540-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202540-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202540-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202540-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202540-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202540-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202540-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202540-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202540-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202540-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202540-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202540-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202540-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202540-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202540-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202540-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202540-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202540-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202540-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202540-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202540-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202540-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202540-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202540-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202540-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202540-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202540-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202540-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202540-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202540-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202540-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202540-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202540-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202540-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202540-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202540-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202540-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202540-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202540-002	AB	1	`bb7c543d1eb4…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ursodiol	URSODIOL	Bryant Ranch Prepack	f527a42c-a6ec-4a0b-a3d8-6c7eba38733c	2026-07-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202540 application number: ANDA202540 ndc (product): 63629-2286
Ursodiol	URSODIOL	Major Pharmaceuticals	e1f6abfd-2158-4824-b53d-717fbe6de3f9	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202540 application number: ANDA202540 ndc (product): 0904-6890
Ursodiol	URSODIOL	Par Health USA, LLC	1a3a8942-94d4-4292-bf74-0a67d92acb90	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202540 application number: ANDA202540 ndc (product): 49884-412 ndc (product): 49884-413
Ursodiol	URSODIOL	AvKARE	0c7e1aa2-704c-435d-e063-6394a90a2d08	2026-01-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202540 application number: ANDA202540
Ursodiol	URSODIOL	Cardinal Health 107, LLC	61dcaec8-3acb-4ef0-afde-65a66e99afa7	2025-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202540 application number: ANDA202540
Ursodiol	URSODIOL	Bryant Ranch Prepack	46cfd68f-9a6e-4a00-a3e7-11d130b571fe	2024-10-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202540 application number: ANDA202540
Ursodiol	URSODIOL	Bryant Ranch Prepack	be811c61-5f48-4b03-94b6-e6941b595621	2024-05-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202540 application number: ANDA202540
Ursodiol	URSODIOL	Bryant Ranch Prepack	5e6ced5f-b8ef-4e6b-a7c1-730bac650c5b	2023-12-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202540 application number: ANDA202540 ndc (product): 63629-2287

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6890	Ursodiol	Ursodiol	Major Pharmaceuticals	ANDA	Current
0904-6890	Ursodiol	Ursodiol	Major Pharmaceuticals	ANDA	Current
0904-6890	Ursodiol	Ursodiol	Major Pharmaceuticals	ANDA	Current
49884-412	Ursodiol	Ursodiol	Par Pharmaceutical, Inc.	ANDA	Current
49884-413	Ursodiol	Ursodiol	Par Pharmaceutical, Inc.	ANDA	Current
63629-2286	Ursodiol	Ursodiol	Bryant Ranch Prepack	ANDA	Current
63629-2286	Ursodiol	Ursodiol	Bryant Ranch Prepack	ANDA	Current
63629-2287	Ursodiol	Ursodiol	Bryant Ranch Prepack	ANDA	Current
63629-2287	Ursodiol	Ursodiol	Bryant Ranch Prepack	ANDA	Current
63629-8353	Ursodiol	Ursodiol	Bryant Ranch Prepack	ANDA	Current
69189-0413	Ursodiol	Ursodiol	Avera McKennan Hospital	ANDA	Current