Application 214849

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

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 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
A214849-001	URSODIOL	URSODIOL	300MG	CAPSULE / ORAL	AB		2022-11-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214849-001	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	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214849-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2022-11-28	`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	A214849-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214849-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214849-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214849-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214849-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214849-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214849-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214849-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214849-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214849-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214849-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214849-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214849-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214849-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214849-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214849-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214849-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214849-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214849-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214849-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214849-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214849-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214849-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214849-001	AB	1	`3bdfa0b2c4d7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214849-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ursodiol	URSODIOL	Bryant Ranch Prepack	b2605f6a-b72d-4773-8d2c-39acfe81e424	2026-04-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214849 application number: ANDA214849
Ursodiol	URSODIOL	Aurobindo Pharma Limited	631339fc-548d-4cd5-8cf3-60e1590f79f6	2025-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214849 application number: ANDA214849 ndc (product): 59651-421
Ursodiol	URSODIOL	NorthStar Rx LLC	dd0346e2-5ff3-4208-ad88-d09182684603	2025-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214849 application number: ANDA214849

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59651-421	Ursodiol	Ursodiol	Aurobindo Pharma Limited	ANDA	Current