Application 077895

Type: ANDA
Sponsor: IMPAX LABS INC

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
A077895-001	URSODIOL	URSODIOL	300MG	CAPSULE / ORAL			2006-07-27

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 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077895-001	URSODIOL	300MG	CAPSULE / ORAL	2006-07-27	`f41ea6bd6efb…`

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 3 of 3 · 42 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Urso 250	URSODIOL	Allergan, Inc.	e8fc4fc2-fe5c-4cba-b6e0-5ceaf2157a61	2023-01-12	Warnings, Adverse reactions	Name fallback generic name: URSODIOL
Ursodiol	URSODIOL	PuraCap Laboratories, LLC	4a161c84-141c-4741-8d69-31a6f3dfd18d	2021-10-01	Adverse reactions	Name fallback brand name: Ursodiol generic name: URSODIOL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.